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NCI CANCERLIT® Search: Chemotherapy for Breast Cancer - July 2002
National Cancer Institute®
Last Modified: July 1, 2002
- Tamoxifen therapy for primary breast cancer and risk of contralateral breast cancer.
- Tamoxifen and contralateral breast cancer: the other side.
- Polychemotherapy for early breast cancer: an overview of the randomised clinical trials with quality-adjusted survival analysis.
- Polychemotherapy for early breast cancer.
- Five-day infusion of fluorouracil and vinorelbine for advanced breast cancer patients treated previously with anthracyclines.
- Systemic therapy.
- Side effects of chemotherapy and combined chemohormonal therapy in women with early-stage breast cancer.
- Living in it, living with it, and moving on: dimensions of meaning during chemotherapy.
- Nucleoside transport inhibitors, dipyridamole and p-nitrobenzylthioinosine, selectively potentiate the antitumor activity
- Combined analysis of two phase II trials in patients with primary and advanced breast cancer with epidoxorubicin and docetaxel+granulocyte
- Dexrazoxane cardioprotection for patients receiving FAC chemotherapy: a pharmacoeconomic evaluation.
- Reader suggests fuller appreciation of findings.
- Letrozole, a new oral aromatase inhibitor for advanced breast cancer: double-blind randomized trial showing a dose effect and improved
- Superior efficacy of letrozole versus tamoxifen as first-line therapy for postmenopausal women with advanced breast cancer: results of a phase
- Aromatase inhibitors: treatment of advanced breast cancer.
- Approval summary: letrozole in the treatment of postmenopausal women with advanced breast cancer.
- Safety and efficacy of the multidrug resistance inhibitor Incel (biricodar; VX-710) in combination with paclitaxel for advanced breast
- Association of high-dose cyclophosphamide, cisplatin, and carmustine pharmacokinetics with survival, toxicity, and dosing weight in patients
- Research will help chemotherapy patients avoid memory loss.
- Breast cancer face-off.
- False shortening of time to progression in letrozole 2.5-mg dose?
- Prognostic value of (99m)Tc-sestamibi washout in predicting response of locally advanced breast cancer to neoadjuvant chemotherapy.
- Superior survival with capecitabine plus docetaxel combination therapy in anthracycline-pretreated patients with advanced breast cancer: phase
- Evaluating neoadjuvant chemotherapy in breast cancer.
- Long-term survival after regional chemotherapy for liver metastases from breast cancer. A case report.
- The evolution of tamoxifen therapy in breast cancer: selective oestrogen-receptor modulators and downregulators.
- Unusual port presentation.
- Aromatase inhibitors for the endocrine adjuvant treatment of breast cancer.
- Anastrozole alone or in combination with tamoxifen versus tamoxifen alone for adjuvant treatment of postmenopausal women with early breast
- Use of capecitabine as first-line therapy in patients with metastatic breast cancer relapsing after high-dose chemotherapy and autologous stem
- Lacrimal duct stenosis and other ocular toxicity associated with adjuvant cyclophosphamide, methotrexate and 5-fluorouracil combination
- Chemoprevention of breast cancer: implications for postmenopausal women.
- [Guidelines for proper use of antineoplastic agents. Breast cancer]
- N-terminal acylation of somatostatin analog with long chain fatty acids enhances its stability and anti-proliferative activity in human breast
- New paradigms in the treatment of breast and colorectal cancer--an introduction.
- Clinical experience of capecitabine in metastatic breast cancer.
- Increased oral bioavailability of topotecan in combination with the breast cancer resistance protein and P-glycoprotein inhibitor GF120918.
- Endocrine effects of nonsteroidal aromatase inhibitors and their clinical impact.
- Pre-operative endocrine therapy for postmenopausal women: when and why?
- Preoperative treatment of postmenopausal breast cancer patients with letrozole: A randomized double-blind multicenter study.
- Formestane, a steroidal aromatase inhibitor after failure of non-steroidal aromatase inhibitors (anastrozole and letrozole): is a
- Weekly paclitaxel as first-line chemotherapy and trastuzumab in patients with advanced breast cancer. A Hellenic Cooperative Oncology Group phase
- Aromatase inhibitors in breast cancer.
- PP1 phosphatase is involved in Bcl-2 dephosphorylation after prolonged mitotic arrest induced by paclitaxel.
- Genistein inhibits tamoxifen effects on cell proliferation and cell cycle arrest in T47D breast cancer cells.
- [Chemotherapy and immunotherapy of metastasized breast carcinoma]
- [New therapeutic approaches: stem cell assisted high dose chemotherapy and molecular techniques in breast carcinoma]
- Acute and subacute toxicity associated with concurrent adjuvant radiation therapy and paclitaxel in primary breast cancer therapy.
- Gemcitabine and vinorelbine combination in patients with metastatic breast cancer.
- New approaches to breast cancer: oxaliplatin combined with 5-fluorouracil and folinic acid in pretreated advanced breast cancer
- Short-term effects of anastrozole treatment on insulin-like growth factor system in postmenopausal advanced breast cancer patients.
- [CGS20267 (Letrozole), a new aromatase inhibitor: late phase II study for postmenopausal women with advanced or recurrent breast cancer (no.
- Phase I trial of edatrexate in advanced breast and other cancers.
- Is there life after methotrexate?
- A rapid and systematic review of the effectiveness and cost-effectiveness of the taxanes used in the treatment of advanced
- Effect of resveratrol on the expression of autocrine growth modulators in human breast cancer cells.
- Stick with tried-and-true breast cancer treatment.
- Older women with breast cancer being managed more aggressively.
- Temporal interrelationships among fatigue, circadian rhythm and depression in breast cancer patients undergoing chemotherapy treatment.
- A phase II study of intravenous navelbine and doxorubicin combination in previously untreated advanced breast carcinoma.
- Preoperative therapy in breast cancer: lessons from the treatment of locally advanced disease.
- Adjuvant therapy for breast cancer: recommendations for management based on consensus review and recent clinical trials.
- High-dose chemotherapy in breast cancer: where are we now?
- Anemia and epoetin alfa in high-dose chemotherapy programs for breast cancer patients.
- Huge response to letrozole in inoperable T4 breast cancer: a case report.
- Successful management of breast cancer with liver metastases with medroxyprogesterone acetate treatment.
- World's largest breast cancer treatment trial supports anastrozole use.
- Changes in apoptosis, mitosis, Her-2, p53 and Bcl2 expression in breast carcinomas after short-term tamoxifen treatment.
- Tumour microvessel density as predictor of chemotherapy response in breast cancer patients.
- Differential interactions between IGFBP-3 and transforming growth factor-beta (TGF-beta) in normal vs cancerous breast epithelial cells.
- Prognostic importance of tumor angiogenesis in breast carcinoma with adjuvant chemotherapy.
- Pemetrexed: translational research in breast cancer.
- Tamoxifen and toremifene treatment of breast cancer and risk of subsequent endometrial cancer: a population-based case-control study.
- [Multicenter open study with docetaxel. Treatment of patients with locally advanced or metastatic breast carcinoma]
- Significance of secondary ultrasonographic endometrial thickening in postmenopausal tamoxifen-treated women.
- Assessment of histologic features and expression of biomarkers in predicting pathologic response to anthracycline-based neoadjuvant
- A phase I dose-escalating study of DaunoXome, liposomal daunorubicin, in metastatic breast cancer.
- Immune changes in patients with advanced breast cancer undergoing chemotherapy with taxanes.
- Raloxifene for the treatment and prevention of breast cancer?
- Acute toxicity of adjuvant doxorubicin and cyclophosphamide for early breast cancer -- a retrospective review of Chinese patients and
- Phase II trial of gemcitabine plus trastuzumab in metastatic breast cancer patients previously treated with chemotherapy: preliminary
- Pemetrexed (Alimta) and gemcitabine in breast cancer patients previously treated with anthracyclines and taxanes.
- Gemcitabine plus cisplatin for the treatment of metastatic breast cancer.
- Gemcitabine/anthracycline combinations in metastatic breast cancer.
- Gemcitabine in combination with vinorelbine for treatment of advanced breast cancer.
- Neoadjuvant gemcitabine therapy for breast cancer.
- Gemcitabine in breast cancer: future directions.
- Overview: gemcitabine as single-agent therapy for advanced breast cancer.
- Tamoxifen effects on subjective and psychosexual well-being, in a randomised breast cancer study comparing high-dose and standard-dose
- Evaluation of long term cardiotoxicity after epirubicin containing adjuvant chemotherapy and locoregional radiotherapy for breast cancer
- Duration of adjuvant chemotherapy for breast cancer: a joint analysis of two randomised trials investigating three versus six courses of CMF.
- Higher expression of human kallikrein 10 in breast cancer tissue predicts tamoxifen resistance.
- Promising results for Arimidex and Femara.
- To block estrogen's synthesis or action: that is the question.
Table of Contents
1
UI - 11438566
AU - Li CI; Malone KE; Weiss NS; Daling JR
TI -
Tamoxifen therapy for primary breast cancer and risk of contralateral
breast cancer.
SO - J Natl Cancer Inst 2001 Jul 4;93(13):1008-13
AD - Division of Public Health Sciences, Fred Hutchinson Cancer Research
Center, Seattle, WA 98109-1024, USA. cili@fhcrc.org
BACKGROUND: Women diagnosed with breast cancer have a twofold to sixfold
greater risk of developing contralateral breast cancer than women in the
general population have of developing a first breast cancer. Tamoxifen
therapy reduces this risk, but it is unclear if this benefit exists for
both estrogen receptor (ER)-positive and ER-negative contralateral
tumors. METHODS: Using data from a population-based tumor registry that
collects information on the ER status of breast tumors, we followed 8981
women residing in western Washington State who were diagnosed with a
primary unilateral invasive breast cancer during the period from 1990
through 1998 to identify cases of contralateral breast cancer. We
restricted our analyses to women who were at least 50 years old and
whose first breast cancer had a localized or regional stage; women who
received adjuvant hormonal therapy but not chemotherapy (n = 4654) were
classified as tamoxifen users, while those who received neither adjuvant
hormonal therapy nor chemotherapy (n = 4327) were classified as nonusers
of tamoxifen. By reviewing selected patient abstracts, we estimated that
94% of the subjects were classified correctly with respect to tamoxifen
use. The risk of contralateral breast cancer associated with tamoxifen
use was estimated with the use of Cox regression. All statistical tests
were two-sided. RESULTS: Of the 89 tamoxifen users and 100 nonusers of
tamoxifen diagnosed with contralateral breast cancer, 112 had
ER-positive tumors, 20 had ER-negative tumors, and 57 had tumors with an
ER status that was unknown or had not been determined by an
immunohistochemical assay. The risk of developing an ER-positive and an
ER-negative contralateral tumor among tamoxifen users was 0.8 (95%
confidence interval [CI] = 0.5 to 1.1) and 4.9 (95% CI = 1.4 to 17.4),
respectively, times that of nonusers of tamoxifen. This difference in
risk by ER status was statistically significant (P<.0001). CONCLUSIONS:
Tamoxifen use appears to decrease the risk of ER-positive contralateral
breast tumors, but it appears to increase the risk of ER-negative
contralateral tumors.
2
UI - 11438553
AU - Swain SM
TI -
Tamoxifen and contralateral breast cancer: the other side.
SO - J Natl Cancer Inst 2001 Jul 4;93(13):963-5
3
UI - 11498214
AU - Cole BF; Gelber RD; Gelber S; Coates AS; Goldhirsch A
TI -
Polychemotherapy for early breast cancer: an overview of the randomised
clinical trials with quality-adjusted survival analysis.
SO - Lancet 2001 Jul 28;358(9278):277-86
AD - Dartmouth College Medical School, Lebanon, NH, USA.
bernard.cole@dartmouth.edu
BACKGROUND: Overview analysis involving 18000 women with breast cancer
in 47 randomised trials showed that prolonged chemotherapy significantly
reduces the risk of relapse and death compared with no chemotherapy.
Here we express the size of the benefit in terms of quality-adjusted
survival time gained. METHODS: We used the Q-TWiST method
(Quality-adjusted Time Without Symptoms of disease and Toxicity of
treatment) to provide treatment comparisons within 10 years' follow-up,
incorporating differences in quality of life associated with times
patients spend with chemotherapy toxic effects, after relapse, and
without symptoms of relapse or toxicity. FINDINGS: Within 10 years'
follow-up the benefit of increased relapse-free and overall survival for
younger women (<50 years old) who received polychemotherapy balanced the
burdens in terms of acute toxic side-effects, especially among women
enrolled in trials that did not include tamoxifen. Overall,
chemotherapy-treated younger women gained an average of 10.3 months of
relapse-free survival and 5.4 months of overall survival within 10 years
(p<0.0001 for both) compared with the no-chemotherapy group.
Polychemotherapy provided more quality-adjusted time than control across
nearly all values of utility weights for time spent undergoing
chemotherapy and time after relapse. The range of benefit was from -0.6
to 10.3 months. For older women (50-69 years) overall, polychemotherapy
also provided significant benefit compared with no chemotherapy but,
compared with younger women, the size of benefit was less and the range
of utility-weight values favouring polychemotherapy was smaller. Average
gains for older women treated with polychemotherapy (with or without
tamoxifen) were 6.8 months of relapse-free survival (p<0.0001) and 2.9
months of overall survival (p=0.0001) within 10 years. The range of
quality-adjusted benefit was -3.1 to 6.8 months. For older women with
oestrogen-receptor-poor tumours who did not receive tamoxifen (9% of the
total), the benefit of polychemotherapy was significant and similar to
that observed for younger women. INTERPRETATION: The benefits of
adjuvant chemotherapy within 10 years outweigh the burdens especially
for younger women (<50 years old) and among older women (50-69 years) to
a lesser degree. Additional studies to compare the quality-adjusted
survival of chemotherapy plus endocrine therapy versus endocrine therapy
alone are required for younger patients with tumours that express
steroid-hormone receptors.
4
UI - 11784664
AU - Rodger A
TI -
Polychemotherapy for early breast cancer.
SO - Lancet 2001 Dec 22-29;358(9299):2170
5
UI - 12067140
AU - Pienkowski T; Jagiello-Gruszfeld A
TI -
Five-day infusion of fluorouracil and vinorelbine for advanced breast
cancer patients treated previously with anthracyclines.
SO - Int J Clin Pharmacol Res 2001;21(3-4):111-7
AD - Department of Breast Cancer and Reconstructive Surgery, Maria
Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology,
Warsaw, Poland.
Vinorelbine has proven to be effective in pretreated metastatic breast
cancer patients. In particular, no cross-resistance with anthracyclines
has been demonstrated. Protracted 5-fluorouracil infusion presents a
better pharmacological profile than its bolus administration. The aim of
this study was to investigate the efficacy and toxicity of the
combination of these two antitumor drugs in patients with metastatic
breast cancer who had been previously treated with
65 patients were enrolled into the study The most important inclusion
criteria were as follows: Karnofsky 70-100, measurable or evaluable
disease and normal renal, hepatic, bone marrow and cardiac function.
Mean age was 48 years (range: 31-70). Fourteen of the 65 women had
already received more than one chemotherapy line. Twenty-three patients
had previously been treated with taxanes. Sites of involvement were the
lungs in 50% of the patients, the liver in 37%, soft tissue in 72%, bone
in 58% and other sites in 32%. Treatment consisted of vinorelbine 25
mg/m2 administered on days 1 and 6 every 21 days and 5-fluorouracil 700
mg/m2/day for 5 consecutive days. The total number of cycles was 340
(mean: five cycles). The treatment was well tolerated. Febrile
neutropenia was observed in 4.6% of patients. Fourteen percent of
patients experienced grade 3 or 4 neutropenia, and 3% experienced grade
3 thrombocytopenia. Grade 3 stomatitis was observed in 9.2% of patients,
grade 3 neurologic toxicity was observed in 1.5%, and grade 3
cardiotoxicity in 4.6%. Grade 3 site reaction occurred in 3% of
patients. Sixty patients were evaluated for response. One patient (1.7%)
attained complete clinical response and 28 (46.7%) attained partial
response. In 22 patients (36.6%) stable disease was documented and nine
patients (15%) progressed while on treatment. Median time to progression
was 24 weeks, median duration of response was 35 weeks and median
overall survival was 41 weeks. Vinorelbine with 5-day infusion of
5-fluorouracil presented high therapeutic activity in breast cancer
patients previously treated with anthracyclines, with acceptable
toxicity.
6
UI - 11673683
AU - Wolff AC
TI -
Systemic therapy.
SO - Curr Opin Oncol 2001 Nov;13(6):436-49
AD - The Johns Hopkins Oncology Center, The Johns Hopkins University School
of Medicine, Baltimore, Maryland 21231-1000, USA. awolff@jhmi.edu
A large body of data on systemic therapy has been presented and
published in the past year, including new information on primary risk
reduction, patient selection for adjuvant systemic therapy, and
anthracycline-analogs. New data on ongoing adjuvant trials (including
taxane studies), unpublished updates from the fourth Oxford Overview in
Development Conference on Adjuvant Therapy for Breast Cancer. Important
new data on anti-estrogen therapy, including aromatase inhibitors and
pure antiestrogens, further expand the role of the oldest targeted
breast cancer therapy. Trastuzumab and other novel compounds are being
investigated as single-agents and in combination with conventional
systemic approaches. Discussions on the long-term effects of adjuvant
therapy have taken center stage also. These and other important ongoing
developments since 2000 are examined in this review article.
7
UI - 11773307
AU - Partridge AH; Burstein HJ; Winer EP
TI -
Side effects of chemotherapy and combined chemohormonal therapy in women
with early-stage breast cancer.
SO - J Natl Cancer Inst Monogr 2001;(30):135-42
AD - Breast Oncology Center, Dana-Farber Cancer Institute, 44 Binney Street,
Boston, MA 02215, USA.
The decision to receive chemotherapy or chemohormonal therapy involves
careful consideration of both the potential benefits and possible risks
of therapy. There are substantial short- and long-term side effects from
chemotherapy. By convention, short-term side effects include those toxic
effects encountered during chemotherapy, while long-term side effects
include later complications of treatment arising after the conclusion of
adjuvant chemotherapy. These side effects vary, depending on the
specific agents used in the adjuvant regimen as well as on the dose used
and the duration of treatment. There is also considerable variability in
side effect profile across individuals. This review will focus on the
short- and long-term toxicity seen with the most commonly used adjuvant
chemotherapy and chemohormonal therapy regimens.
8
UI - 11817485
AU - Richer MC; Ezer H
TI -
Living in it, living with it, and moving on: dimensions of meaning
during chemotherapy.
SO - Oncol Nurs Forum 2002 Jan-Feb;29(1):113-9
AD - McGill University Health Center, Montreal, Quebec, Canada.
marie-claire.richer@muhc.mcgill.ca
PURPOSE/OBJECTIVE: To explore the meanings assigned to the experience of
receiving chemotherapy. DESIGN: Descriptive exploratory. SETTING: An
oncology outpatient clinic in a university hospital in Montreal, Quebec,
Canada. SAMPLE: Ten women with breast cancer who experienced
chemotherapy for the first time. METHODS: Semistructured interview using
a grounded theory approach. FINDINGS: Women described three dimensions
of their experience with breast cancer and chemotherapy: "living in it,"
"living with it," and "moving on." Existential and situational meanings
were an integral part of their experience. The existential meaning
seemed to be present in varying degrees of intensity throughout the
treatment, whereas the situational meanings were predominant at the
beginning of the treatment phase and became less important as the
treatment progressed. CONCLUSIONS: The intrapersonal and interpersonal
dimensions of the chemotherapy experience as well as the capacity to
move on evolve within a context of both situational and existential
meanings. IMPLICATIONS FOR NURSING PRACTICE: The study results suggest
the potential value of exploring each woman's inner world of meanings in
relation to her sense of self, relationships with others, resources, and
coping strategies during treatment for breast cancer. Because
existential and situational meanings are an integral part of women's
experience, the nurse's role is to create an environment that permits
and facilitates dialogue about these dimensions of meaning.
9
UI - 11914638
AU - Boyer CR; Karjian PL; Wahl GM; Pegram M; Neuteboom ST
TI -
Nucleoside transport inhibitors, dipyridamole and
p-nitrobenzylthioinosine, selectively potentiate the antitumor activity
of NB1011.
SO - Anticancer Drugs 2002 Jan;13(1):29-36
AD - NewBiotics, Inc, San Diego, CA 92121, USA.
NB1011, a novel anticancer agent, targets tumor cells expressing high
levels of thymidylate synthase (TS). NB1011 is converted intracellularly
to bromovinyldeoxyuridine monophosphate (BVdUMP) which competes with the
natural substrate, deoxyuridine monophosphate, for binding to TS. Unlike
inhibitors, NB1011 becomes a reversible substrate for TS catalysis.
Thus, TS retains activity and converts BVdUMP into cytotoxic product(s).
In vitro cytotoxicity studies demonstrate NB1011's preferential activity
against tumor cells expressing elevated TS protein levels. Additionally,
NB1011 has antitumor activity in vivo. To identify drugs which interact
synergistically with NB1011, we screened 13 combinations of
chemotherapeutic agents with NB1011 in human tumor and normal cells.
Dipyridamole and p-nitrobenzylthioinosine (NBMPR), potent inhibitors of
equilibrative nucleoside transport, synergized with NB1011 selectively
against 5-fluorouracil (5-FU)-resistant H630R10 colon carcinoma cells
[combination index (CI)=0.75 and 0.35] and Tomudex-resistant MCF7TDX
breast carcinoma cells (CI=0.51 and 0.57), both TS overexpressing cell
lines. These agents produced no synergy with NB1011 in Det551 and
CCD18co normal cells (CI > 1.1) lacking TS overexpression. Dipyridamole
potentiated NB1011's cytotoxicity in medium lacking nucleosides and
bases, suggesting a non-salvage-dependent mechanism. We demonstrate that
nucleoside transport inhibitors, dipyridamole and NBMPR, show promise
for clinically efficacious combination with NB1011.
10
UI - 11914643
AU - Wenzel C; Locker GJ; Schmidinger M; Rudas M; Taucher S; Gnant MF; Jakesz
TI -
R; Steger GG
Combined analysis of two phase II trials in patients with primary and
advanced breast cancer with epidoxorubicin and docetaxel+granulocyte
colony stimulating factor.
SO - Anticancer Drugs 2002 Jan;13(1):67-74
AD - Department of Internal Medicine I, Division of Oncology, University
Hospital of Vienna, 1090 Vienna, Austria.
Anthracyclines and taxanes are to date the most active cytotoxic agents
in the treatment of breast cancer, and a combination of these is
therefore considered to result in the highest response rates in the
neoadjuvant, as well as in palliative treatment. These two phase II
studies aimed to evaluate the feasibility, toxicity and activity of a
cytostatic regimen combining epidoxorubicin and docetaxel in outpatient
patients suffering from breast cancer. In total, 104 consecutive
patients were enrolled in these prospective clinical trials. The
chemotherapeutic regimen consisted of epidoxorubicin [75 mg/m2 body
surface area (BSA)] and docetaxel (75 mg/m2 BSA) on day 1 accompanied by
the administration of granulocyte colony stimulating factor on days
3-10, repeated every 3 weeks (ED+G). Sixty-six patients received ED+G as
neoadjuvant and 38 patients as palliative treatment, respectively.
Patients received a total of 566 cycles (median: 6 cycles, range: 2-11
cycles) of this therapeutic regimen. Outpatient ED+G was well tolerated.
A major response to preoperative ED+G could be demonstrated in 54 of 66
patients (82%) and in 22 of 38 palliative treated patients (58%). We
conclude that outpatient ED+G is safe in the neoadjuvant and palliative
treatment of patients suffering from breast cancer by showing a
favorable side effect and activity profile. Thus, this regimen can be
considered for further clinical trials.
11
UI - 12056098
AU - Tonkin K; Bates M; Lieu D; Arundell E; Williamson T; Zagari M
TI -
Dexrazoxane cardioprotection for patients receiving FAC chemotherapy: a
pharmacoeconomic evaluation.
SO - Can J Oncol 1996 Nov;6(2):458-73
AD - London Regional Cancer Centre, London, Ontario.
Anthracyclines are among the most effective and commonly-prescribed
antitumor agents but have dose-limiting cumulative cardiotoxicity. We
performed a pharmacoeconomic evaluation of the ability of dexrazoxane to
prevent cardiac-related adverse events in patients with Stage IIIB or IV
metastatic breast cancer who were treated with a median of 10 cycles of
intravenous FAC (5-fluorouracil, doxorubicin and cyclophosphamide) at
doses of 500/50/500 mg/m2 respectively. Dexrazoxane was given at 500
mg/m2 commencing at the seventh cycle of treatment. We determined the
cost of each cardiac event prevented and the cost of each additional
life-year saved by dexrazoxane use. The cost per cardiac event prevented
was CDN $5745 and the cost per additional life-year saved was CDN $2856.
With the increasing use of anthracyclines in Stages I and II breast
cancer, these favorable clinical and economic results may broaden the
range of therapeutic possibilities for anthracyclines in adjuvant and
metastatic therapy of breast cancer.
12
UI - 12064322
AU - Carroll-Johnson RM
TI -
Reader suggests fuller appreciation of findings.
SO - Oncol Nurs Forum 2002 Jun;29(5):751; discussion 751
13
UI - 9469328
AU - Dombernowsky P; Smith I; Falkson G; Leonard R; Panasci L; Bellmunt J;
TI -
Bezwoda W; Gardin G; Gudgeon A; Morgan M; Fornasiero A; Hoffmann W;
Michel J; Hatschek T; Tjabbes T; Chaudri HA; Hornberger U; Trunet PF
Letrozole, a new oral aromatase inhibitor for advanced breast cancer:
double-blind randomized trial showing a dose effect and improved
efficacy and tolerability compared with megestrol acetate.
SO - J Clin Oncol 1998 Feb;16(2):453-61
PURPOSE: To compare two doses of letrozole and megestrol acetate (MA) as
second-line therapy in postmenopausal women with advanced breast cancer
previously treated with antiestrogens. PATIENTS AND METHODS: Five
hundred fifty-one patients with locally advanced, locoregionally
recurrent or metastatic breast cancer were randomly assigned to receive
letrozole 2.5 mg (n = 174), letrozole 0.5 mg (n = 188), or MA 160 mg (n
= 189) once daily in a double-blind, multicenter trial. Data were
analyzed for tumor response and safety variables up to 33 months of
follow-up evaluation and for survival up to 45 months. RESULTS:
Letrozole 2.5 mg produced a significantly higher overall objective
response rate (24%) compared with MA (16%; logistic regression, P = .04)
or letrozole 0.5 mg (13%; P = .004). Duration of objective response was
significantly longer for letrozole 2.5 mg compared with MA (Cox
regression, P = .02). Letrozole 2.5 mg was significantly superior to MA
and letrozole 0.5 mg in time to treatment failure (P = .04 and P = .002,
respectively). For time to progression, letrozole 2.5 mg was superior to
letrozole 0.5 mg (P = .02), but not to MA (P = .07). There was a
significant dose effect in overall survival in favor of letrozole 2.5 mg
(P = .03) compared with letrozole 0.5 mg. Letrozole was significantly
better tolerated than MA with respect to serious adverse experiences,
discontinuation due to poor tolerability, cardiovascular side effects,
and weight gain. CONCLUSION: The data show letrozole 2.5 mg once daily
to be more effective and better tolerated than MA in the treatment of
postmenopausal women with advanced breast cancer previously treated with
antiestrogens.
14
UI - 11352951
AU - Mouridsen H; Gershanovich M; Sun Y; Perez-Carrion R; Boni C; Monnier A;
TI -
Apffelstaedt J; Smith R; Sleeboom HP; Janicke F; Pluzanska A; Dank M;
Becquart D; Bapsy PP; Salminen E; Snyder R; Lassus M; Verbeek JA;
Staffler B; Chaudri-Ross HA; Dugan M
Superior efficacy of letrozole versus tamoxifen as first-line therapy
for postmenopausal women with advanced breast cancer: results of a phase
III study of the International Letrozole Breast Cancer Group.
SO - J Clin Oncol 2001 May 15;19(10):2596-606
AD - Rigshospitalet, Copenhagen, Denmark.
PURPOSE: To compare the efficacy and tolerability of tamoxifen with that
of letrozole, an oral aromatase inhibitor, with tamoxifen as first-line
therapy in postmenopausal women with advanced breast cancer. PATIENTS
AND METHODS: Nine hundred seven patients were randomly assigned
letrozole 2.5 mg once daily (453 patients) or tamoxifen 20 mg once daily
(454 patients). Patients had estrogen receptor- and/or progesterone
receptor-positive tumors, or both receptors were unknown. Recurrence
during adjuvant antiestrogen therapy or within the following 12 months
or prior endocrine therapy for advanced disease precluded enrollment.
One prior chemotherapy regimen for metastatic disease was allowed. The
primary end point was time to progression (TTP). Secondary end points
included overall objective response rate (ORR), its duration, rate and
duration of clinical benefit, time to treatment failure (TTF), overall
survival, and tolerability. RESULTS: TTP was significantly longer for
letrozole than for tamoxifen (median, 41 v 26 weeks). Treatment with
letrozole reduced the risk of progression by 30% (hazards ratio, 0.70;
95% confidence interval, 0.60 to 0.82, P =.0001). TTP was significantly
longer for letrozole irrespective of dominant site of disease, receptor
status, or prior adjuvant antiestrogen therapy. Similarly, TTF was
significantly longer for letrozole (median, 40 v 25 weeks). ORR was
higher for letrozole (30% v 20%; P =.0006), as was the rate of clinical
benefit (49% v 38%; P =.001). Survival data are currently immature and
not reported here. Both treatments were well tolerated. CONCLUSION:
Letrozole was significantly superior to tamoxifen in TTP, TTF, ORR, and
clinical benefit rate. Our results support its use as first-line
endocrine therapy in postmenopausal women with advanced breast cancer.
15
UI - 11579125
AU - Panasci LC
TI -
Aromatase inhibitors: treatment of advanced breast cancer.
SO - J Clin Oncol 2001 Oct 1;19(19):3999-4000
16
UI - 11895893
AU - Cohen MH; Johnson JR; Li N; Chen G; Pazdur R
TI -
Approval summary: letrozole in the treatment of postmenopausal women
with advanced breast cancer.
SO - Clin Cancer Res 2002 Mar;8(3):665-9
AD - Division of Oncology Drug Products (HFD-150), Center for Drug Evaluation
and Research, Food and Drug Administration, Rockville, Maryland 20857,
USA. cohenm@cder.fda.gov
Letrozole (Femara; Novartis Pharmaceuticals Corp., East Hanover, NJ) is
a nonsteroidal inhibitor of aromatase enzyme complex. It inhibits the
peripheral conversion of circulating androgens to estrogens. In
postmenopausal women, letrozole decreases plasma concentrations of
estradiol, estrone, and estrone sulfate by 75-95% from baseline with
maximal suppression achieved within 2-3 days of treatment initiation.
Suppression is dose related, with doses of >or=0.5 mg giving estrone and
estrone sulfate values that were often below assay detection limits. At
clinically used dosage, letrozole does not impair adrenal synthesis of
glucocorticoids or aldosterone. In 1998, letrozole was approved by the
United States Food and Drug Administration (FDA) for the treatment of
advanced breast cancer in postmenopausal women, with hormone receptor
positive or unknown breast cancer, who had failed one prior antiestrogen
treatment (i.e., for "second-line" treatment). Approval was based on two
randomized trials comparing tumor RRs of patients receiving 0.5 mg of
letrozole, 2.5 mg of letrozole, and either megestrol acetate (MA) or
aminoglutethimide. In the megestrol trial, 2.5 mg/day letrozole was
superior to 0.5 mg of letrozole and MA (RRs 24, 13, and 16%,
respectively), whereas in the aminoglutethimide trial, there was no
significant difference in 2.5 mg of letrozole and 0.5 mg of letrozole
RRs (20 and 17%). There was a trend toward RR superiority of 2.5 mg of
letrozole over aminoglutethimide (P = 0.06). Letrozole (2.5 mg) was the
dose chosen for comparison with tamoxifen in the first-line setting. In
postmenopausal women with hormone receptor positive or hormone receptor
unknown locally advanced or metastatic breast cancer was submitted to
the FDA. A single double-blind, double dummy, randomized, and
multicenter trial compared 2.5 mg of letrozole to 20 mg of tamoxifen
(456 patients/arm). Letrozole was superior to tamoxifen with regard to
time to progression (TTP) and objective response rate (RR). The median
TTP for letrozole treatment was 9.9 months [95% confidence interval (CI)
9.1-12.2] versus 6.2 months (95% CI 5.8-8.5) for tamoxifen, P = 0.0001,
hazard ratio 0.713, (95% CI 0.61-0.84). RR was 32% for letrozole versus
21% for tamoxifen (odds ratio 1.74, 95% CI 1.29-2.34, P = 0.0003).
Preliminary survival data (survival data are still blinded) indicate
that letrozole is unlikely to be worse than tamoxifen. Both treatments
were similarly tolerated. On the basis of these results, the United
States FDA approved letrozole tablets, 2.5 mg/day, for first-line
treatment of postmenopausal women with hormone receptor-positive or
hormone receptor-unknown locally advanced or metastatic breast cancer.
The manufacturer made a commitment to provide updated information on
survival.
17
UI - 11895894
AU - Toppmeyer D; Seidman AD; Pollak M; Russell C; Tkaczuk K; Verma S;
TI -
Overmoyer B; Garg V; Ette E; Harding MW; Demetri GD
Safety and efficacy of the multidrug resistance inhibitor Incel
(biricodar; VX-710) in combination with paclitaxel for advanced breast
cancer refractory to paclitaxel.
SO - Clin Cancer Res 2002 Mar;8(3):670-8
AD - Cancer Institute of New Jersey, New Brunswick, New Jersey 08903, USA.
PURPOSE: VX-710 (biricodar, Incel) restores drug sensitivity to
P-glycoprotein (MDR1) and multidrug resistance-associated protein
(MRP1)-expressing cells. This Phase II study evaluated the
safety/tolerability, pharmacokinetics, and efficacy of VX-710 plus
paclitaxel in women with locally advanced or metastatic breast cancer
who were refractory to prior paclitaxel therapy. EXPERIMENTAL DESIGN:
Eligible patients had paclitaxel-refractory disease defined as
progressive disease after a minimum of two cycles of paclitaxel (weekly
or 3-week schedule) or relapsed/progressive disease within 6 months of
prior paclitaxel therapy. Patients received 80 mg/m(2) paclitaxel over 3
h starting 4 h after initiation of a 24-h continuous i.v. infusion of
120 mg/m(2)/h VX-710. Cycles were repeated every 3 weeks. RESULTS:
Thirty-seven patients received study treatment and 35 were evaluable for
response. VX-710 + paclitaxel therapy was generally well tolerated.
Myelosuppression was the principal toxicity, with a median nadir ANC
cycle 1 of 0.76 x 10(9) cells/liter and a 40% overall incidence of Grade
4 neutropenia. Nonhematological side effects (asthenia, paresthesia,
headache, myalgia, nausea, and diarrhea) were generally mild to moderate
and reversible. Paclitaxel AUC (16.8 +/- 5.0 microg x h/ml) and
clearance (5.1 +/- 1.3 liters/h/m(2)) during the first treatment cycle
were comparable with standard 175 mg/m(2) paclitaxel administered in a
3-h schedule. Four patients achieved partial responses (three of the
four had progressive disease on prior paclitaxel) with a mean response
duration of 5.5 months. CONCLUSIONS: The 11.4% (4 of 35) objective
response rate observed in this study suggests that VX-710 can
resensitize a subgroup of paclitaxel-refractory patients to paclitaxel.
The safety and pharmacokinetics of the VX-710/pacitaxel regimen support
further evaluation in breast cancer patients with initial paclitaxel
therapy to prevent emergence of the MDR phenotype in recurrent disease.
18
UI - 11895898
AU - Petros WP; Broadwater G; Berry D; Jones RB; Vredenburgh JJ; Gilbert CJ;
TI -
Gibbs JP; Colvin OM; Peters WP
Association of high-dose cyclophosphamide, cisplatin, and carmustine
pharmacokinetics with survival, toxicity, and dosing weight in patients
with primary breast cancer.
SO - Clin Cancer Res 2002 Mar;8(3):698-705
AD - Bone Marrow Transplant Program, Duke University Medical Center, Durham,
North Carolina 27710, USA. wpetros@hsc.wvu.edu
This report investigates relationships between the pharmacokinetics and
pharmacodynamics of high-dose alkylators used for the treatment of
primary breast cancer. Eighty-five women with primary breast cancer
involving >or=10 lymph nodes received four cycles of standard-dose
chemotherapy followed by a high-dose regimen consisting of:
cyclophosphamide (1875 mg/m(2) once daily x 3), cisplatin (165 mg/m(2)
given over 72 h), carmustine (600 mg/m(2)), and stem cell
transplantation. Dosages were attenuated in patients whose body weight
exceeded their calculated ideal weight by >20%. Pharmacokinetics of the
high-dose chemotherapeutic agents were evaluated in each patient by
collection and analysis of serial blood samples. Area under the
concentration time curve (AUC) for cyclophosphamide and carmustine was
highly variable (>10-fold inter-patient range) with coefficients of
variation > 50%, in contrast to cisplatin exposures (2-fold range;
coefficient of variation 12%). The dosing method for overweight patients
resulted in significantly lower systemic exposure to cisplatin (P =
0.035). The parent cyclophosphamide clearance on the 1st day of
administration was significantly higher in patients who experienced
acute cardiac toxicity (n = 5; P = 0.011), whereas carmustine
disposition was not found to be different in those developing pulmonary
toxicity (n = 25; P = 0.96). Kaplan-Meier analysis (median follow-up of
5.9 years) demonstrated that patients with lower cyclophosphamide AUC
(faster parent drug clearance to potentially cytotoxic compounds)
survived longer (P = 0.031). Inter-individual differences in the
pharmacokinetic disposition of high-dose chemotherapy may explain
variability in both response and toxicity. Prospective strategies, which
attempt to individualize AUC, should be evaluated in this setting.
19
UI - 12048744
AU - Anonymous
TI -
Research will help chemotherapy patients avoid memory loss.
SO - W V Med J 2002 Mar-Apr;98(2):78
20
UI - 12066455
AU - Brink S
TI -
Breast cancer face-off.
SO - US News World Rep 2002 Jun 3;132(19):54
21
UI - 11731525
AU - Cocconi G
TI -
False shortening of time to progression in letrozole 2.5-mg dose?
SO - J Clin Oncol 2001 Dec 1;19(23):4353; discussion 4354-5
22
UI - 12050317
AU - Sciuto R; Pasqualoni R; Bergomi S; Petrilli G; Vici P; Belli F; Botti C;
TI -
Mottolese M; Maini CL
Prognostic value of (99m)Tc-sestamibi washout in predicting response of
locally advanced breast cancer to neoadjuvant chemotherapy.
SO - J Nucl Med 2002 Jun;43(6):745-51
AD - Department of Nuclear Medicine, Regina Elena Cancer Institute, Rome,
Italy. sciuto@ifo.it
This study evaluated the role of (99m)Tc-sestamibi washout in the
prediction of pathologic tumor response to neoadjuvant chemotherapy in
30 patients with locally advanced breast cancer. METHODS: Two
(99m)Tc-sestamibi studies were performed before and after chemotherapy
for each patient. Early (10 min) and delayed (240 min) planar breast
views were acquired after a 740-MBq (99m)Tc-sestamibi intravenous
injection, and the washout rate (WOR) was computed. All patients
underwent radical mastectomy with pathologic evaluation of the residual
tumor size. RESULTS: The pretherapy (99m)Tc-sestamibi WOR ranged from
14% to 92% (mean +/- SD, 50% +/- 18%). At pathologic examination, 15
patients showed no tumor response to chemotherapy and 15 patients showed
an objective response to chemotherapy. The pretherapy (99m)Tc-sestamibi
study predicted chemoresistance (WOR > 45%) in 18 of 30 patients and no
chemoresistance (WOR < or = 45%) in 12 of 30 patients. When the WOR
cutoff was set at >45%, the prognostic performance of the test was
indicated by a sensitivity of 100%; a specificity of 80%; positive and
negative predictive values of 83% and 100%, respectively; and a
likelihood ratio of 5. The repeatability of the test was good, with
80%-93% interreader agreement (kappa = 0.57-0.85). Posttherapy
(99m)Tc-sestamibi studies confirmed the pretherapy study prediction in
29 of 30 patients. CONCLUSION: (99m)Tc-Sestamibi WOR is a reliable test
for predicting tumor response to neoadjuvant chemotherapy. In fact,
negative findings (WOR < or = 45%) rule out chemoresistance and positive
findings (WOR > 45%) indicate a high risk of chemoresistance.
23
UI - 12065558
AU - O'Shaughnessy J; Miles D; Vukelja S; Moiseyenko V; Ayoub JP; Cervantes
TI -
G; Fumoleau P; Jones S; Lui WY; Mauriac L; Twelves C; Van Hazel G; Verma
S; Leonard R
Superior survival with capecitabine plus docetaxel combination therapy
in anthracycline-pretreated patients with advanced breast cancer: phase
III trial results.
SO - J Clin Oncol 2002 Jun 15;20(12):2812-23
AD - Baylor-Sammons Cancer Center, Dallas, TX 75246, USA.
joyce.o'shaughnessey@usoncology.com
PURPOSE: Docetaxel and capecitabine, a tumor-activated oral
fluoropyrimidine, show high single-agent efficacy in metastatic breast
cancer (MBC) and synergy in preclinical studies. This international
phase III trial compared efficacy and tolerability of
capecitabine/docetaxel therapy with single-agent docetaxel in
anthracycline-pretreated patients with MBC. PATIENTS AND METHODS:
Patients were randomized to 21-day cycles of oral capecitabine 1,250
mg/m(2) twice daily on days 1 to 14 plus docetaxel 75 mg/m(2) on day 1
(n = 255) or to docetaxel 100 mg/m(2) on day 1 (n = 256). RESULTS:
Capecitabine/docetaxel resulted in significantly superior efficacy in
time to disease progression (TTP) (hazard ratio, 0.652; 95% confidence
interval [CI], 0.545 to 0.780; P =.0001; median, 6.1 v 4.2 months),
overall survival (hazard ratio, 0.775; 95% CI, 0.634 to 0.947; P =.0126;
median, 14.5 v 11.5 months), and objective tumor response rate (42% v
30%, P =.006) compared with docetaxel. Gastrointestinal side effects and
hand-foot syndrome were more common with combination therapy, whereas
myalgia, arthralgia, and neutropenic fever/sepsis were more common with
single-agent docetaxel. More grade 3 adverse events occurred with
combination therapy (71% v 49%, respectively), whereas grade 4 events
were slightly more common with docetaxel (31% v 25% with combination).
CONCLUSION: The significantly superior TTP and survival achieved with
the addition of capecitabine to docetaxel 75 mg/m(2), with the
manageable toxicity profile, indicate that this combination provides
clear benefits over single-agent docetaxel 100 mg/m(2).
Docetaxel/capecitabine therapy is an important treatment option for
women with anthracycline-pretreated MBC.
24
UI - 12065569
AU - Lawrence G; Crawford J; Sherman F
TI -
Evaluating neoadjuvant chemotherapy in breast cancer.
SO - J Clin Oncol 2002 Jun 15;20(12):2905-6; discussion 2906-7
25
UI - 12088260
AU - Tekin K; Kocaoglu H; Bayar S
TI -
Long-term survival after regional chemotherapy for liver metastases from
breast cancer. A case report.
SO - Tumori 2002 Mar-Apr;88(2):167-9
AD - Department of General Surgery, Faculty of Medicine, Pamukkale
University, Denizli, Turkey. koraytekin@hotmail.com
The prognosis of patients with liver metastases from breast cancer has
to be regarded as rather unfavorable. A 45-year-old woman with cancer of
the left breast and multiple simultaneous liver metastases was initially
treated with cyclophosphamide, methotrexate, and 5-fluorouracil. After
two treatment cycles a sonogram of the left breast revealed reduction of
the tumor size and she underwent a modified radical mastectomy and
hepatic artery catheterization. There was no change in the multiple
lesions of the liver on abdominal ultrasonography. One week later a
regional chemotherapy regimen was given through a hepatic arterial
catheter with subcutaneous implanted reservoir. After completion of the
seventh course of chemotherapy, ultrasonography revealed that the
there has been no relapse during the seven-year follow-up period. In
conclusion, we suggest that intra-arterial regional chemotherapy may
have an important role to play in the management of breast cancer
patients with isolated liver metastases.
26
UI - 12067682
AU - O'Regan RM; Jordan VC
TI -
The evolution of tamoxifen therapy in breast cancer: selective
oestrogen-receptor modulators and downregulators.
SO - Lancet Oncol 2002 Apr;3(4):207-14
AD - Robert H Lurie Comprehensive Cancer Center, Northwestern University,
Chicago, IL 60611, USA.
Tamoxifen is the most widely used hormonal treatment for all stages of
breast cancer and has been approved for the prevention of breast cancer
in high-risk women. The observation that tamoxifen acts as an
antioestrogen on the breast but has paradoxical oestrogenic effects on
bones and lipids heralded the development of the selective
oestrogen-receptor modulators (SERM). Raloxifene, another of these
drugs, is being used to prevent osteoporosis in postmenopausal women,
but it seems, like tamoxifen, to prevent breast cancer. The molecular
basis for these target-site-specific actions remains unclear but may
involve the relative expressions of coregulatory proteins in target
tissues. Several new SERM agents are in clinical development in an
attempt to decrease the unwanted effects. Furthermore, two different
classes of hormonal agents, the aromatase inhibitors and
oestrogen-receptor downregulators, which have no oestrogen-like
properties at any site, are promising new treatments for breast cancer.
27
UI - 11899369
AU - Camp-Sorrell D
TI -
Unusual port presentation.
SO - Clin J Oncol Nurs 2001 May-Jun;5(3):115-6
AD - Central Alabama Hematology Oncology Associates Alabaster, USA.
28
UI - 12090973
AU - Ravdin P
TI -
Aromatase inhibitors for the endocrine adjuvant treatment of breast
cancer.
SO - Lancet 2002 Jun 22;359(9324):2126-7
AD - Department of Medical Oncology, University of Texas Health Science
Center, San Antonio, TX 98284-7884, USA. peter@oncology.uthscsa.edu
29
UI - 12090977
AU - The ATAC Trialists' Group. Arimidex, tamoxifen alone or in combination.
TI -
Anastrozole alone or in combination with tamoxifen versus tamoxifen
alone for adjuvant treatment of postmenopausal women with early breast
cancer: first results of the ATAC randomised trial.
SO - Lancet 2002 Jun 22;359(9324):2131-9
BACKGROUND: In the adjuvant setting, tamoxifen is the established
treatment for postmenopausal women with hormone-sensitive breast cancer.
However, it is associated with several side-effects including
endometrial cancer and thromboembolic disorders. We aimed to compare the
safety and efficacy outcomes of tamoxifen with those of anastrozole
alone and the combination of anastrozole plus tamoxifen for 5 years.
METHODS: Participants were postmenopausal patients with invasive
operable breast cancer who had completed primary therapy and were
eligible to receive adjuvant hormonal therapy. The primary endpoints
were disease-free survival and occurrence of adverse events. Analysis
for efficacy was by intention to treat. FINDINGS: 9366 patients were
recruited, of whom 3125 were randomly assigned anastrozole, 3116
tamoxifen, and 3125 combination. Median follow-up was 33.3 months. 7839
(84%) patients were known to be hormone-receptor-positive. Disease-free
survival at 3 years was 89.4% on anastrozole and 87.4% on tamoxifen
(hazard ratio 0.83 [95% CI 0.71-0.96], p=0.013). Results with the
combination were not significantly different from those with tamoxifen
alone (87.2%, 1.02 [0.89-1.18], p=0.8). The improvement in disease-free
survival with anastrozole was seen in the subgroup of
hormone-receptor-positive patients, but not the receptor-negative
patients. Incidence of contralateral breast cancer was significantly
lower with anastrozole than with tamoxifen (odds ratio 0.42 [0.22-0.79],
p=0.007). Anastrozole was significantly better tolerated than tamoxifen
with respect to endometrial cancer (p=0.02), vaginal bleeding and
discharge (p<0.0001 for both), cerebrovascular events (p=0.0006), venous
thromboembolic events (p=0.0006), and hot flushes (p<0.0001). Tamoxifen
was significantly better tolerated than anastrozole with respect to
musculoskeletal disorders and fractures (p<0.0001 for both).
INTERPRETATION: Anastrozole is an effective and well tolerated endocrine
option for the treatment of postmenopausal patients with
hormone-sensitive early breast cancer. Longer follow-up is required
before a final benefit:risk assessment can be made.
30
UI - 11824880
AU - Bashey A; Sundaram S; Corringham S; Jones V; Lancaster D; Silva-Gietzen
TI -
J; Law P; Ball ED
Use of capecitabine as first-line therapy in patients with metastatic
breast cancer relapsing after high-dose chemotherapy and autologous stem
cell support.
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