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Abramson Cancer CenterNCI CANCERLIT® Search: Chemotherapy for Breast Cancer - September 2002
National Cancer Institute®
Last Modified: September 1, 2002
- High-dose chemotherapy in advanced breast cancer.
- Fulvestrant (faslodex) for advanced breast cancer.
- A significant response to neoadjuvant chemotherapy in BRCA1/2 related breast cancer.
- Endometrial mixed Mullerian tumor with heterologous elements following tamoxifen therapy for breast cancer: a case report and literature
- Aromatase inhibitors.
- Letrozole in the treatment of breast cancer.
- Clinical use of GnRH analogues.
- Growth, morphological and biochemical changes in oxa-spermine derivative-treated MCF-7 human breast cancer cells.
- The clinical effectiveness of trastuzumab for breast cancer: a systematic review.
- The development and clinical use of trastuzumab (Herceptin).
- A rose is no longer a rose.
- Double-blind, randomized trial comparing the efficacy and tolerability of fulvestrant versus anastrozole in postmenopausal women with advanced
- Fulvestrant, formerly ICI 182,780, is as effective as anastrozole in postmenopausal women with advanced breast cancer progressing after prior
- [Use of clodronate in the adjuvant treatment of breast cancer is questionable for the time being]
- Pure antiestrogens and breast cancer.
- Preoperative transcatheter arterial infusion chemotherapy for locally advanced breast cancer (stage IIIb) for down-staging and increase of
- New alternative to tamoxifen.
- Randomized, placebo-controlled trial of clodronate in patients with primary operable breast cancer.
- American Society of Clinical Oncology technology assessment on the use of aromatase inhibitors as adjuvant therapy for women with hormone
- HER-2/neu serum levels vis-a-vis hormonal response in metastatic breast cancer.
- Breast cancer: adjuvant therapy with anthracyclines.
- Randomized trial of adjuvant chemotherapy for operable breast cancer comparing i.v. CMF to an epirubicin-containing regimen [see comment]
- Continuous infusional 5-fluorouracil in breast cancer or the revival of an old drug?
- Low-dose continuous intravenous infusion of 5-fluorouracil for metastatic breast cancer.
- Estimating the benefits of adjuvant systemic therapy for women with early breast cancer.
- Factors influencing the prognostic role of oestrogen and progesterone receptor levels in breast cancer--results of the analysis of 670
- Predictors of long-term outcome following high-dose chemotherapy in high-risk primary breast cancer.
- Effect of neoadjuvant treatment with anastrozole on tumour histology in postmenopausal women with large operable breast cancer.
- A population-based study on the first forty-eight breast cancer patients receiving trastuzumab (Herceptin) on a named patient basis in Sweden.
- Second malignancies following CMF-based adjuvant chemotherapy in resectable breast cancer.
- Utility of the SEER-Medicare data to identify chemotherapy use.
- Trait anxiety and tamoxifen effects on bone mineral density and sex hormone- binding globulin.
- Development of cross-resistance to tamoxifen in raloxifene-treated breast carcinoma cells.
- Antisense ferritin oligonucleotides inhibit growth and induce apoptosis in human breast carcinoma cells.
- Fulvestrant, an estrogen receptor downregulator, reduces cell turnover index more effectively than tamoxifen.
- Cyclophosphamide, methotrexate and fluorouracil (CMF) versus hormonal ablation with leuprorelin acetate as adjuvant treatment of
- 3-year results of docetaxel-based sequential and combination regimens in the adjuvant therapy of node-positive breast cancer: a pilot study.
- Low-dose oral methotrexate and cyclophosphamide in metastatic breast cancer: antitumor activity and correlation with vascular endothelial
- High-dose chemotherapy in high-risk primary breast cancer.
- Pegylated liposomal doxorubicin with vinorelbine in metastatic breast carcinoma. A phase I-II clinical investigation.
- Adjuvant therapy for all patients with breast cancer?
- Re: Prognosis and treatment of patients with breast tumors of one centimeter or less and negative axillary lymph nodes.
- Dose-dense anthracycline-based chemotherapy for node-positive breast cancer.
- Prospective exploratory analysis of the association between tumor response, quality of life, and expenditures among patients receiving
- Reversible pancytopenia caused by oral letrozole assumption in a patient with recurrent breast cancer.
- Anastrozole versus tamoxifen as first-line therapy for advanced breast cancer: methodologic issues.
- Eniluracil's need for a targeted approach: a lesson in drug development.
- Tamoxifen enhances interferon-regulated gene expression in breast cancer cells.
- Overexpression of IRF9 confers resistance to antimicrotubule agents in breast cancer cells.
- Breast cancer chemoprevention: current challenges and a look toward the future.
- Adjuvant chemotherapy with doxorubicin and cyclophosphamide in women with rapidly proliferating node-negative breast cancer.
- A clinical study of taxotere versus taxotere plus the antiprolactinemic agent bromocriptine in metastatic breast cancer pretreated with
- Neutropenic infections add significant costs to palliative chemotherapy in breast cancer.
- Phase II study of receptor-enhanced chemosensitivity using recombinant humanized anti-p185HER2/neu monoclonal antibody plus cisplatin in
- Pathobiology of preoperative chemotherapy: findings from the National Surgical Adjuvant Breast and Bowel (NSABP) protocol B-18.
- Concurrent cyclophosphamide, methotrexate, and 5-fluorouracil chemotherapy and radiotherapy for breast carcinoma: a well tolerated
- Photoeruption in a patient treated with capecitabine (Xeloda) for metastatic breast cancer.
- Efficacy and economics of hormonal therapies for advanced breast cancer.
- A phase II trial of fractionated vinorelbine/doxorubicin as first-line therapy for advanced breast cancer.
- Enhanced benefit from adjuvant chemotherapy in breast cancer patients classified high-risk according to urokinase-type plasminogen activator
- Cyclosporin A enhances the apoptotic effects of N-(4-hydroxyphenyl)retinamide in breast cancer cells.
- Docetaxel secretion in tears: association with lacrimal drainage obstruction.
- Treating young patients with breast cancer. The evidence suggests that all should be treated with adjuvant therapy.
- Weight gain during adjuvant and neoadjuvant chemotherapy for breast cancer: an audit of 100 women receiving FEC or CMF chemotherapy.
- Equivalence between ovarian suppression and chemotherapy in the adjuvant treatment of endocrine-responsive breast cancer.
- Meeting highlights: International consensus panel on the treatment of primary breast cancer.
- Predictive factors for response to chemotherapy in advanced breast cancer.
- Does famotidine enhance tumor infiltrating lymphocytes in breast cancer? Results of a randomized prospective pilot study.
- [The role of aromatase inhibitors in the treatment of breast neoplasms. An evaluation of clinical efficacy and the tolerability profile]
- New drugs for breast cancer.
- Overexpression of wild-type breast cancer resistance protein mediates methotrexate resistance.
Table of Contents
1
UI - 11856590
AU - Viens P; Maraninchi D
TI -
High-dose chemotherapy in advanced breast cancer.
SO - Crit Rev Oncol Hematol 2002 Feb;41(2):141-9
AD - Department of Medicine, Institut Paoli Calmettes, Marseille, France.
oncomed@marseille.fnclcc.fr
Based on in vitro and animals studies which assess dose effect
relationship specially for alkylating agent, and on the importance on
dose intensity in human protocols, high-dose chemotherapy with stem cell
support has been widely evaluated in various tumours, particularly in
breast cancer. Moreover, in the last few years, the utilization of
hematopoietic growth factors and peripheral stem cells has permitted a
large diffusion of this approach. However, there is not yet clear data
on the place of such a treatment in breast cancer. Few randomized trials
are available, with mature data. Only one shows an advantage for
high-dose therapy in metastatic disease. In adjuvant setting, sample
sizes are too small or follow-up not long enough to draw any definitive
conclusion on the place of high-dose consolidation chemotherapy in
breast cancer. In inflammatory breast cancer, which is a much more less
frequent disease, encouraging results have been published in phase two
studies, looking at pathological response, or in pilot studies. The next
few years will give a mature date of randomized trials which evaluate
high-dose chemotherapy given after conventional treatment in metastatic
or high risk disease. Effort should be done to better evaluate this
strategy in terms of cost and quality of life and to design new studies
aimed to evaluate front line multiple intensification.
2
UI - 12138378
AU - Anonymous
TI -
Fulvestrant (faslodex) for advanced breast cancer.
SO - Med Lett Drugs Ther 2002 Jul 22;44(1135):65-6
3
UI - 12161606
AU - Chappuis PO; Goffin J; Wong N; Perret C; Ghadirian P; Tonin PN; Foulkes
TI -
WD
A significant response to neoadjuvant chemotherapy in BRCA1/2 related
breast cancer.
SO - J Med Genet 2002 Aug;39(8):608-10
4
UI - 11858901
AU - Kaleli S; Calay Z; Altinok T; Kosebay D
TI -
Endometrial mixed Mullerian tumor with heterologous elements following
tamoxifen therapy for breast cancer: a case report and literature
review.
SO - Eur J Obstet Gynecol Reprod Biol 2002 Mar 10;101(2):204-8
AD - Department of Obstetrics and Gynecology, Cerrahpasa Medical School,
Istanbul University, P.O. Box 11, Cerrahpasa, 34000, Istanbul, Turkey.
semihkaleli@yahoo.com
CASE: A 67-year-old multiparous woman received 20mg tamoxifen daily for
four years after surgical treatment of breast cancer. She presented with
vaginal bleeding. Uterine curettage revealed a uterine MMT with
heterologous elements. She was treated surgically with adjuvant
radiotherapy. Tumor cells were found to be estrogen receptor negative
and progesterone receptor positive. Uterine MMT may be linked to long
term use of tamoxifen. A mechanism in developing MMT other than estrogen
receptor pathway may be possible.
5
UI - 11900315
AU - Cunnick GH; Mokbel K
TI -
Aromatase inhibitors.
SO - Curr Med Res Opin 2001;17(3):217-22
AD - St George's Breast Cancer Centre, St George's Hospital, London, UK.
The new non-steroidal and steroidal aromatase inhibitors are at least as
effective as megestrol acetate (MA) as second-line hormonal agents in
postmenopausal women with breast cancer. However, they are superior to
MA in terms of tolerability and adverse effects. Letrozole and
exemestane have been shown to be superior to MA in terms of efficacy.
Furthermore, exemestane and anastrozole demonstrated a survival
advantage over MA. These drugs are therefore considered established
second-line hormonal agents. There is a growing body of evidence
supporting the role of third-generation aromatase inhibitors as
first-line therapy for ER-and/or PgR-positive advanced breast cancer in
postmenopausal women, and as a neoadjuvant therapy in postmenopausal
women with hormone receptor positive tumours unsuitable for breast
conserving surgery. Studies comparing these drugs head-to-head and with
adjuvant tamoxifen are currently in progress. The potential role of
these drugs in breast cancer prevention is worth investigating.
6
UI - 11996638
AU - Shaw HS; Ellis MJ
TI -
Letrozole in the treatment of breast cancer.
SO - Expert Opin Pharmacother 2002 May;3(5):607-17
AD - Multidisciplinary Breast Program, Duke University Medical Center, Box
3381, Durham, NC 27710, USA. shaw0002@mc.duke.edu
Over the last 30 years the role of tamoxifen in breast cancer treatment
has been progressively expanded by clinical investigation to encompass
the entire spectrum of disease from cancer chemoprevention to palliation
of advanced disease. The primacy of tamoxifen for these indications in
postmenopausal women is now under challenge by the selective aromatase
inhibitors, a class of endocrine agent that induces oestrogen
deprivation rather than oestrogen receptor blockade. This review
considers the biochemical, pharmacological and clinical properties of
the nonsteroidal aromatase inhibitor letrozole. This agent is superior
to tamoxifen for the treatment of metastatic breast cancer, a finding
that suggests that letrozole may ultimately eclipse tamoxifen for other
indications, including chemoprevention. Further clinical investigation
will be necessary to establish the risks and benefits of letrozole
versus tamoxifen for each new indication, with adjuvant therapy being
the next in line. The object of this review is to provide a reference
source on the biochemical, pharmacological and clinical properties of
letrozole for clinicians to consider both established and future
indications.
7
UI - 12072036
AU - Kiesel LA; Rody A; Greb RR; Szilagyi A
TI -
Clinical use of GnRH analogues.
SO - Clin Endocrinol (Oxf) 2002 Jun;56(6):677-87
AD - Department of Obstetrics and Gynaecology, University of Muenster,
Germany. l.kiesel@uni-muenster.de
8
UI - 12095537
AU - Pavlov V; Rodilla V; Kong Thoo Lin P
TI -
Growth, morphological and biochemical changes in oxa-spermine
derivative-treated MCF-7 human breast cancer cells.
SO - Life Sci 2002 Jul 26;71(10):1161-73
AD - Department of Human and Animal Physiology, Faculty of Biology,
University of Sofia St. Kliment Ohridski, Dr. Tzankov Blvd. 8, 1164
Sofia, Bulgaria. vpavlov@biofac.uni-sofia.bg
The growth inhibitory properties of two oxa-spermine derivatives named
compound 1 and compound 2, representatives of a novel type of polyamine
derivatives, were studied. Dose-response growth inhibitory curves
obtained after 48h drug exposure demonstrated the much higher cytotoxic
activity of compound 1 towards MCF-7 human breast cancer cells. Further
experiments with compound 1 showed that this oxa-spermine derivative
exhibited considerable cytotoxicity with IC(50) values of 3.74 microM
and 2.93 microM after 24h and 48h drug exposure respectively. In MCF-7
cells, after 8h drug (10 microM) exposure it caused shrinkage, chromatin
condensation and nuclear fragmentation. However, no clear DNA laddering
was detected in treated cells. Drug treatment provoked an increase in
polyamine oxidase (PAO) activity. This enzyme is able to produce
cytotoxic H(2)O(2) and 3-acetamidopropanal, catalyzing the oxidative
deamination of N(1)-acetylated derivatives of spermine and spermidine to
spermidine and putrescine respectively. Taken together these data
demonstrate that the novel oxa-polyamine derivative compound 1 has
considerable cytotoxic activity towards MCF-7 cells and indicate that an
induction of PAO may be involved in its cytotoxic and apoptotic effects.
9
UI - 12137722
AU - Lewis R; Bagnall AM; Forbes C; Shirran E; Duffy S; Kleijnen J; Riemsma
TI -
R; ter Riet G
The clinical effectiveness of trastuzumab for breast cancer: a
systematic review.
SO - Health Technol Assess 2002;6(13):1-71
AD - NHS Centre for Reviews and Dissemination, University of York, UK.
10
UI - 12121832
AU - Harries M; Smith I
TI -
The development and clinical use of trastuzumab (Herceptin).
SO - Endocr Relat Cancer 2002 Jun;9(2):75-85
AD - Breast Unit, The Royal Marsden Hospital and Institute of Cancer
Research, Fulham Rd, London SW3 6JJ, UK. mark.harries@rmh.nthames.nhs.uk
HER-2 is a member of the c-erbB family of receptor tyrosine kinases and
is overexpressed by 20-30% of human breast cancers. HER-2 overexpression
is an independent adverse prognostic factor and may also predict for
response to both chemotherapy and endocrine agents. Trastuzumab is a
humanised monoclonal antibody that binds with high affinity to the
extracellular domain of HER-2. In HER-2-overexpressing preclinical
models trastuzumab has been shown to have a marked antiproliferative
effect and demonstrates synergy with a number of cytotoxic drugs.
Several phase II and phase III clinical trials have now been performed
in patients with advanced breast cancer that overexpress HER-2.
Trastuzumab was initially shown to be active and well tolerated as a
single agent in heavily pretreated women. Subsequently, studies of
first-line treatment for metastatic breast cancer have demonstrated an
improvement in survival for trastuzumab when used in combination with
either paclitaxel or an anthracycline-cyclophosphamide regimen compared
with chemotherapy alone. Unexpectedly, the combination of trastuzumab
and the anthracycline-containing regimen was associated with a
significant incidence of cardiac dysfunction. The benefit of trastuzumab
is generally confined to patients whose tumours have gene amplification
as detected by fluorescence in situ hybridisation (FISH) and this is
tightly associated with immunohistochemical (IHC) staining at the
highest (3+) level. A small number of patients have IHC 2+ tumours
together with FISH evidence of gene amplification and may also derive
benefit from treatment. Trastuzumab has also been shown to be effective
when used as first-line monotherapy for advanced breast cancer. Trials
to date have employed trastuzumab in a weekly schedule, but there is
emerging evidence that a three-weekly regimen may be as effective.
Trastuzumab has shown encouraging activity when used with other agents
including docetaxel and vinorelbine. The combination of trastuzumab,
docetaxel, and platinum salts also appears to be very active. The role
of trastuzumab as adjuvant therapy for early breast cancer is being
tested in a number of large randomised trials.
11
UI - 12177095
AU - Henderson IC
TI -
A rose is no longer a rose.
SO - J Clin Oncol 2002 Aug 15;20(16):3365-8
12
UI - 12177098
AU - Osborne CK; Pippen J; Jones SE; Parker LM; Ellis M; Come S; Gertler SZ;
TI -
May JT; Burton G; Dimery I; Webster A; Morris C; Elledge R; Buzdar A
Double-blind, randomized trial comparing the efficacy and tolerability
of fulvestrant versus anastrozole in postmenopausal women with advanced
breast cancer progressing on prior endocrine therapy: results of a North
American trial.
SO - J Clin Oncol 2002 Aug 15;20(16):3386-95
AD - Breast Center at Baylor College of Medicine, 1 Baylor Plaza, MS 600,
Houston, TX 77030, USA. kosborne@breastcenter.tmc.edu
PURPOSE: To compare the efficacy and tolerability of fulvestrant
(formerly ICI 182,780) with anastrozole in the treatment of advanced
breast cancer in patients whose disease progresses on prior endocrine
treatment. PATIENTS AND METHODS: In this double-blind, double-dummy,
parallel-group study, postmenopausal patients were randomized to receive
either an intramuscular injection of fulvestrant 250 mg once monthly or
a daily oral dose of anastrozole 1 mg. The primary end point was time to
progression (TTP). Secondary end points included objective response (OR)
rate, duration of response (DOR), and tolerability. RESULTS: Patients (n
= 400) were followed for a median period of 16.8 months. Fulvestrant was
as effective as anastrozole in terms of TTP (hazard ratio, 0.92; 95.14%
confidence interval [CI], 0.74 to 1.14; P =.43); median TTP was 5.4
months with fulvestrant and 3.4 months with anastrozole. OR rates were
17.5% with both treatments. Clinical benefit rates (complete response +
partial response + stable disease > or = 24 weeks) were 42.2% for
fulvestrant and 36.1% for anastrozole (95% CI, -4.00% to 16.41%; P
=.26). In responding patients, median DOR (from randomization to
progression) was 19.0 months for fulvestrant and 10.8 months for
anastrozole. Using all patients, DOR was significantly greater for
fulvestrant compared with anastrozole; the ratio of average response
durations was 1.35 (95% CI, 1.10 to 1.67; P < 0.01). Both treatments
were well tolerated. CONCLUSION: Fulvestrant was at least as effective
as anastrozole, with efficacy end points slightly favoring fulvestrant.
Fulvestrant represents an additional treatment option for postmenopausal
women with advanced breast cancer whose disease progresses on tamoxifen
therapy.
13
UI - 12177099
AU - Howell A; Robertson JF; Quaresma Albano J; Aschermannova A; Mauriac L;
TI -
Kleeberg UR; Vergote I; Erikstein B; Webster A; Morris C
Fulvestrant, formerly ICI 182,780, is as effective as anastrozole in
postmenopausal women with advanced breast cancer progressing after prior
endocrine treatment.
SO - J Clin Oncol 2002 Aug 15;20(16):3396-403
AD - Department of Medical Oncology, Christie Hospital NHS Trust, Wilmslow
Road, Manchester M20 4BX, United Kingdom.
maria.parker@christie-tr.nwest.nhs.ukto
PURPOSE: To compare the efficacy and tolerability of fulvestrant
(formerly ICI 182,780) and anastrozole in postmenopausal women with
advanced breast cancer progressing after prior endocrine treatment.
PATIENTS AND METHODS: Patients (n = 451) with advanced breast cancer
were randomized to receive fulvestrant 250 mg as a once-monthly (one x 5
mL) intramuscular injection or an oral dose of anastrozole 1 mg in this
open, parallel-group, multicenter trial. The primary end point was time
to progression (TTP). Secondary end points included objective response
(OR) rates, defined as complete response (CR) or partial response (PR),
duration of response (DOR), and tolerability. RESULTS: Patients were
followed for a median period of 14.4 months. In terms of TTP,
fulvestrant was as effective as anastrozole (hazard ratio, 0.98;
confidence interval [CI], 0.80 to 1.21; P =.84). Median TTP was 5.5
months for fulvestrant and 5.1 months for anastrozole. OR rates showed a
numerical advantage for fulvestrant (20.7%) over anastrozole (15.7%)
(odds ratio, 1.38; CI, 0.84 to 2.29; P =.20). Clinical benefit rates (CR
+ PR + stable disease > or = 24 weeks) were 44.6% for fulvestrant and
45.0% for anastrozole. Median DOR was 14.3 months for fulvestrant and
14.0 months for anastrozole. Both treatments were well tolerated, with
3.2% and 1.3% of fulvestrant- and anastrozole-treated patients,
respectively, withdrawn from treatment because of an adverse event.
CONCLUSION: Fulvestrant was as effective as anastrozole. These data
confirm that fulvestrant is an additional, effective, and well-tolerated
treatment for advanced breast cancer in postmenopausal women whose
disease progressed on prior endocrine therapy.
14
UI - 12116460
AU - Elomaa I; Saarto T
TI -
[Use of clodronate in the adjuvant treatment of breast cancer is
questionable for the time being]
SO - Duodecim 2001;117(10):1021-2
15
UI - 11922402
AU - Elkak AE; Mokbel K
TI -
Pure antiestrogens and breast cancer.
SO - Curr Med Res Opin 2001;17(4):282-9
AD - The Breast Cancer Centre, St George's Hospital and Medical School,
London, UK.
Tamoxifen, which is the most commonly used drug for treatment of breast
cancer, has both estrogen agonist and antagonist actions. Pure
antiestrogens are devoid of any estrogen agonist effects. ICI 182,780
(fulvestrant) (Faslodex) and ICI 164,384 are competitive inhibitors of
estrogen by binding to the estrogen receptor (ER). Preclinical and
clinical studies show that fulvestrant and ICI 164,384 are more potent
than tamoxifen in inhibiting the growth of breast cancer cells. They are
devoid of any estrogen-agonist action on the uterus and vagina but lack
the beneficial effects of tamoxifen on the bone and serum lipid profile.
Fulvestrant is the first pure antiestrogen to complete phase III
clinical trials. Such studies have shown that fulvestrant is at least as
good as anastrozole in the treatment of post-menopausal women with
advanced breast cancer who had relapsed or progressed on prior endocrine
therapy. The drug was well tolerated and only minor side-effects were
reported. Its potential role in the adjuvant setting will be determined
by its adverse effects on bone mass and serum lipids. EM-800 and EM-652
are the most potent pure antiestrogens and EM-652 has the highest
affinity of all antiestrogens to ER. They have no stimulatory effects on
the uterus or vagina. It seems reasonable to expect that pure
antiestrogens will be good alternatives to tamoxifen and aromatase
inhibitors in the treatment of breast cancer.
16
UI - 12065118
AU - Kitagawa K; Yamakado K; Nakatsuka A; Tanaka N; Matsumura K; Takeda K;
TI -
Kawarada Y
Preoperative transcatheter arterial infusion chemotherapy for locally
advanced breast cancer (stage IIIb) for down-staging and increase of
resectability.
SO - Eur J Radiol 2002 Jul;43(1):31-6
AD - Department of Radiology, Mie University School of Medicine, Tsu, Japan.
kakuya@clin.medic.mie-u.ac.jp
OBJECTIVES: To evaluate the clinical usefulness of preoperative
transcatheter arterial infusion chemotherapy (TAIC) for locally advanced
breast cancer. METHODS: Seven patients with unresectable locally
advanced breast cancer (stage IIIb) underwent TAIC percutaneously 1-3
times (mean, 1.7 times) until tumors became resectable. Anticancer drugs
were injected into both the internal mammary and the distal subclavian
arteries. RESULTS: There was no major complication related to the
procedure. The mean tumor size was significantly decreased from
10.0+/-3.9 to 5.1+/-2.5 cm (P=0.0086). Skin and muscle invasions were
improved in two patients (28%) and lymph nodes disappeared in one
patient (14%). In two patients (28%), down-staging was achieved from
stage IIIb to stage IIIa. All tumors turned into resectable, and
mastectomy was performed with a mean period of 35 days (range 9-60 days)
after TAIC. Marked decrease in tumor size allowed one patient to receive
breast-conserving surgery. There was no local recurrence in any patient.
However, five patients (71%) experienced distant metastases. The 3-year
disease free and overall survival were 0 and 71.4%, respectively.
CONCLUSIONS: TAIC for locally advanced breast cancer is useful in
reducing tumor size and achieving down-staging in a relatively short
period, leading to an expanded surgical indication.
17
UI - 12138025
AU - Anonymous
TI -
New alternative to tamoxifen.
SO - Harv Womens Health Watch 2002 Jul;9(11):7
18
UI - 12149294
AU - Powles T; Paterson S; Kanis JA; McCloskey E; Ashley S; Tidy A;
TI -
Rosenqvist K; Smith I; Ottestad L; Legault S; Pajunen M; Nevantaus A;
Mannisto E; Suovuori A; Atula S; Nevalainen J; Pylkkanen L
Randomized, placebo-controlled trial of clodronate in patients with
primary operable breast cancer.
SO - J Clin Oncol 2002 Aug 1;20(15):3219-24
AD - Royal Marsden National Health Service Trust, Royal Marsden Hospital,
Downs Road, Sutton, Surrey SM2 5PT, UK. trevor.powles@rmh.nthames.nhs.uk
PURPOSE: The development of bone metastases depends on tumor-induced
osteoclastic resorption of bone, which may be inhibited by the
antiosteolytic bisphosphonate clodronate. Given to patients with primary
breast cancer, clodronate might reduce the subsequent incidence of bone
metastases. PATIENTS AND METHODS: This double-blind, multicenter trial
accrued 1,069 assessable patients with operable breast cancer between
1989 and 1995. All patients received surgery, radiotherapy,
chemotherapy, and tamoxifen as required. Patients were randomized to
receive oral clodronate 1,600 mg/d or a placebo for 2 years starting
within 6 months of primary treatment. The primary end point was relapse
in bone, analyzed on an intent-to-treat basis, during the medication
period and during the total follow-up period (median follow-up, 2,007
days). Secondary end points were relapse in other sites, mortality, and
toxicity. RESULTS: During the total follow-up period, there was a
nonsignificant reduction in occurrence of bone metastases (clodronate, n
= 63; placebo, n = 80; hazards ratio [HR], 0.77; 95% confidence interval
[CI], 0.56 to 1.08; P =.127). During the medication period there was a
significant reduction in the occurrence of bone metastases (clodronate,
n = 12; placebo, n = 28; HR, 0.44; 95% CI, 0.22 to 0.86; P =.016). The
occurrence of nonosseous metastases was similar (clodronate, n = 112;
placebo, n = 128; P =.257), but there was a significant reduction in
mortality (clodronate, n = 98; placebo, n = 129; P =.047) during the
total follow-up period. CONCLUSION: Clodronate, given to patients with
primary operable breast cancer, may reduce the occurrence of bone
metastases, although this reduction was only significant during this
medication period. There was a significant reduction in mortality.
19
UI - 12149306
AU - Winer EP; Hudis C; Burstein HJ; Chlebowski RT; Ingle JN; Edge SB;
TI -
Mamounas EP; Gralow J; Goldstein LJ; Pritchard KI; Braun S; Cobleigh MA;
Langer AS; Perotti J; Powles TJ; Whelan TJ; Browman GP
American Society of Clinical Oncology technology assessment on the use
of aromatase inhibitors as adjuvant therapy for women with hormone
receptor-positive breast cancer: status report 2002.
SO - J Clin Oncol 2002 Aug 1;20(15):3317-27
AD - Health Services Research Department, American Society of Clinical
Oncology, 1900 Duke Street, Suite 200, Alexandria, VA 22314, USA.
guidelines@asco.org
OBJECTIVE: To conduct an evidence-based technology assessment to
determine whether the routine use of anastrozole or any of the aromatase
inhibitors in the adjuvant breast cancer setting is appropriate for
broad-based conventional use in clinical practice. POTENTIAL
INTERVENTIONS: Anastrozole, letrozole, and exemestane. OUTCOMES:
Outcomes of interest include breast cancer incidence, breast
cancer-specific survival, overall survival, and net health benefit.
EVIDENCE: A comprehensive, formal literature review was conducted for
relevant topics and is detailed in the text. Testimony was collected
from invited experts and interested parties. The American Society of
Clinical Oncology (ASCO)-prescribed technology assessment procedure was
followed. BENEFITS/HARMS: The ASCO panel recognizes that a woman and her
physician's decision regarding adjuvant hormonal therapy is complex and
will depend on the importance and weight attributed to information
regarding both cancer and non-cancer-related risks and benefits.
CONCLUSION: The panel was influenced by the compelling, extensive, and
long-term data available on tamoxifen. Overall, the panel considers the
results of the Arimidex (anastrozole) or Tamoxifen Alone or in
Combination (ATAC) trial and the extensive supporting data to be very
promising but insufficient to change the standard practice at this time
therapy for women with hormone receptor-positive breast cancer. The
panel recommends that physicians discuss the available information with
patients, and, in making a decision, acknowledge that treatment
approaches can change over time. Individual health care providers and
their patients will need to come to their own conclusions, with careful
consideration of all of the available data. (Specific questions
addressed by the panel are summarized in Appendix 3.) VALIDATION: The
conclusions of the panel were endorsed by the ASCO Health Services
Research Committee and the ASCO Board of Directors.
20
UI - 12149314
AU - Panasci LC
TI -
HER-2/neu serum levels vis-a-vis hormonal response in metastatic breast
cancer.
SO - J Clin Oncol 2002 Aug 1;20(15):3357; discussion 3357
21
UI - 1498056
AU - Bonadonna G; Valagussa P
TI -
Breast cancer: adjuvant therapy with anthracyclines.
SO - Ann Oncol 1992 Jun;3(6):417-8
22
UI - 1498061
AU - Mauriac L; Durand M; Chauvergne J; Dilhuydy JM; Bonichon F
TI -
Randomized trial of adjuvant chemotherapy for operable breast cancer
comparing i.v. CMF to an epirubicin-containing regimen [see comment]
SO - Ann Oncol 1992 Jun;3(6):439-43
AD - Fondation Bergonie, Comprehensive Cancer Center of Southwest of France,
Bordeaux.
than 3 cm were treated by surgery +/- radiotherapy. All of them had
axillary node involvement (N+) and/or lacked estrogen and progesterone
steroid receptors (EPR-). They were randomized in an adjuvant
chemotherapy trial comparing 9 intravenous CMF courses
(cyclophosphamide, methotrexate, 5FU)--113 patients--to a
polychemotherapy consisting of 3 courses of MTV (mitomycin C, thiotepa,
vindesine) plus 3 courses of EVM (epirubicin, vincristine,
methotrexate)--115 patients. Prognostic factors were well balanced
between the two treatment groups. With a 59-month median follow-up,
local breast relapses are more frequent in the CMF group, but regional
and metastatic recurrences are the same in the two groups. Overall
survival is identical. Toxicity is different: alopecia and neurotoxicity
are more frequent in the MTV+EVM group, but general and digestive
toxicities are equivalent. Haematologic toxicity is greater in the CMF
group, requiring more frequent dosage reductions.
23
UI - 8922189
AU - Smith IE
TI -
Continuous infusional 5-fluorouracil in breast cancer or the revival of
an old drug?
SO - Ann Oncol 1996 Oct;7(8):771-2
24
UI - 8922194
AU - Regazzoni S; Pesce G; Marini G; Cavalli F; Goldhirsch A
TI -
Low-dose continuous intravenous infusion of 5-fluorouracil for
metastatic breast cancer.
SO - Ann Oncol 1996 Oct;7(8):807-13
AD - Department of Oncology, Ospedale Civico, Lugano, Switzerland.
BACKGROUND: Third-line chemotherapies for advanced breast cancer are
difficult to tailor to the individual patient because of reduced
tolerance and significant toxicity. Treatment with a continuous
intravenous infusion of low-dose 5-fluorouracil (FU-LDCI) is generally
well tolerated and thus, a reasonable option for heavily pretreated
patients. PATIENTS AND METHODS: From 1989 to 1995, 106 consecutive
patients with advanced breast cancer were treated with FU-LDCI.
5-Fluorouracil was given at an initial daily dose of 250 mg/m2
administered continuously with the aid of an elastomer, non-electronic
pump through a permanent central venous line for 21 days followed by a
7-day rest. The median age was 56 years (range, 30-82), the median ECOG
Performance Status was 1 (range 0-4) and the median number of metastatic
sites was 2 (range 1-4). Sixty-one percent of the patients had
previously received more than 2 chemotherapy regimens which in 81%
included adriamycin, and in 90% 5-fluorouracil. RESULTS: Eighty patients
were evaluable for objective response: 17 of them had partial responses
(21%, 95% CI: 14%-31%) and 23 stable disease (29%, 95% CI: 20%-40%).
One-hundred five patients were evaluable for subjective response, with
46 reporting improvement (44%, 95% CI: 35%-54%). Previous treatments
with either 5-fluorouracil or adriamycin did not predict response to
FU-LDCI. Median time to progression for patients with a partial response
or stable disease was 259 days (range 82-737). The overall survival for
the populations as a whole was 274 days (range 13-2264), and the median
dose received was 1904 mg/week (range 753-4329). The main toxic effects
were grades I and II mucositis, and nausea and vomiting (observed in 31%
and 28%, respectively). Grade III toxicities were uncommon: mucositis in
3%, nausea and vomiting in 3%, anemia, thrombocytopenia and hepatitis in
2%, and skin toxicity (hand-foot syndrome) in 1%. Catheter-related
thrombosis was observed in 2% of the patients, and there were no pump
failures. A questionnaire concerning the impact of the treatment upon
quality of life was completed by all of the 13 patients who were alive
at the time of evaluation of the results, and all of them rated FU-LDCI
as easy to tolerate. The monthly cost of FU-LDCI (US$1,051.00 in
Switzerland) was lower than the cost of weekly low-dose adriamycin
(US$1,483.00 in Switzerland), a treatment which is often used as a
palliative regimen in similar circumstances. CONCLUSION: FU-LDCI is a
useful, cost-effective third-line treatment for patients with metastatic
breast cancer who need palliation with cytotoxic drugs.
25
UI - 11683751
AU - Grogan M; Tabar L; Chua B; Chen HH; Boyages J
TI -
Estimating the benefits of adjuvant systemic therapy for women with
early breast cancer.
SO - Br J Surg 2001 Nov;88(11):1513-8
AD - New South Wales Breast Cancer Institute, Westmead Hospital, University
of Sydney, Westmead, New South Wales, Australia.
BACKGROUND: Prognostic factors are commonly used to help identify women
with node-negative breast cancer at high risk of recurrence. Although
many are available, knowing which risk factor or combination of factors
to use to estimate prognosis for an individual woman is often difficult.
This study documented the baseline prognoses for a group of women with
node-negative breast cancers, and estimated the potential benefits of
adjuvant systemic therapy. METHODS: Ten-year, actuarial, cause-specific
survival based on tumour size and histological grade using data from the
Swedish Two-County Trial of mammographic screening was calculated for
1200 women with node-negative cancers of less than 30 mm diameter. The
benefits of adjuvant systemic therapy for these women were then
estimated using the published odds reductions in death from adjuvant
systemic therapy from the Early Breast Cancer Trialists' Collaborative
Group overview. RESULTS: The absolute 10-year survival benefits for
subgroups of women based on tumour size and histological grade were
estimated for women aged under 50 years by the addition of chemotherapy,
and over 50 years by the addition of tamoxifen and/or chemotherapy.
CONCLUSION: Decisions about adjuvant systemic therapy in women with
node-negative breast cancer need to be individualized, taking into
account treatment efficacy and toxicity. The quantitative methods
presented in this paper facilitate such decisions.
26
UI - 12091062
AU - Costa SD; Lange S; Klinga K; Merkle E; Kaufmann M
TI -
Factors influencing the prognostic role of oestrogen and progesterone
receptor levels in breast cancer--results of the analysis of 670
patients with 11 years of follow-up.
SO - Eur J Cancer 2002 Jul;38(10):1329-34
AD - Department of Obstetrics and Gynecology, University of Frankfurt,
Theodor-Stern-Kai 7, 60590 Frankfurt am Main, Germany.
costa@em.uni-frankfurt.de
In the last two decades, the prognostic role of the steroid hormone
receptors has been the subject of a myriad of publications.
Nevertheless, its relevance after long-term follow-up is still not
clear. The confusion about the prognostic value is mainly due to the
difficulty in comparing analyses. Despite different study-designs and
statistical approaches, oestrogen (ER) and progesterone (PR) receptors
are widely accepted as prognostic factors. Data from 670 breast cancer
patients with a median follow-up of 11.4 years were analysed
retrospectively. ER and PR were measured by the dextran-coated charcoal
(DCC) assay. To investigate the time dependence of the prognostic
relevance of ER and PR, separate analyses were done for follow-up
shorter and longer than 5 years. Special focus was directed at patients
< or =50 and >50 years, node-negative women, in particular those without
adjuvant therapy. Univariate and multivariate analyses were performed.
In univariate analysis, ER and PR were associated with a significantly
longer overall survival at the cut-off levels 10, 20 or 100 fmol/mg
protein. The significant survival benefit occurred in the first 5 years
of follow-up and remained unchanged in the following period. In the
multivariate analyses, only the PR was of significant prognostic value
(for PR> or =20 fmol/mg P=0.036, for PR> or =100 P=0.01, Cox analysis).
In patients younger than 51 years, only PR was an independent
prognosticator at the cut-off level of 100 fmol/mg protein, while in
patients >50 years both hormone receptors were not significant. In N0
patients, only the PR reached long-term prognostic independence at a
cut-off point of > or =100 fmol/mg (P=0.018). In addition, in the group
of node-negative women < or =50 years without adjuvant therapy the PR
level reached prognostic significance. The hormone receptor status was a
prognostic factor only during the first 5 years of follow-up. Our data
suggest that age, lymph node status, length of follow-up and probably
the ER/PR assay are important for the evaluation of ER and PR as
prognostic variables. In most analyses, PR appeared to be superior to ER
in predicting the prognosis of primary breast cancer patients.
27
UI - 12177795
AU - Somlo G; Simpson JF; Frankel P; Chow W; Leong L; Margolin K; Morgan R
TI -
Jr; Raschko J; Shibata S; Forman S; Kogut N; McNamara M; Molina A; Somlo
E; Doroshow JH
Predictors of long-term outcome following high-dose chemotherapy in
high-risk primary breast cancer.
SO - Br J Cancer 2002 Jul 29;87(3):281-8
AD - Department of Medical Oncology and Therapeutics Research, City of Hope
National Medical Center, 1500 E Duarte Road, Duarte, California, CA
91010-3000, USA. gsomlo@coh.org
We report on a predictive model of long-term outcome in 114 high-risk
breast cancer patients treated with high-dose chemotherapy between 1989
and 1994. Paraffin-blocks from 90 of the 114 primaries were assessed for
the presence of five risk factors: grade, mitotic index, protein
expression of p53, HER2/neu, and oestrogen/progesterone receptor status;
we could analyse the effect of risk factors in 84 of these 90 tumours.
Seven-year relapse-free and overall survival was 58% (95% confidence
interval 44-74%) and 82% (95% confidence interval 71-94%) vs 33% (95%
confidence interval 21-52%) and 41% (95% confidence interval 28-60%) for
patients whose primary tumours displayed > or =3 risk factors vs
patients with < or =2 risk factors. For the entire group of 168
high-risk breast cancer patients, inflammatory stage IIIB disease and
involved post-mastectomy margins were associated with decreased
relapse-free survival and overall survival; patients treated with
non-doxorubicin containing standard adjuvant therapy experienced worse
overall survival (RR, 2.08; 95% confidence interval 1.04 to 4.16;
P=0.04), while adjuvant tamoxifen improved overall survival (RR, 0.65;
95% confidence interval 0.41-1.01; P=0.054). Future trial designs and
patient selection for studies specific for high-risk breast cancer
patients should include appropriate prognostic models. Validation of
such models could come from recently completed randomised, prospective
trials. Copyright 2002 Cancer Research UK
28
UI - 12177804
AU - Anderson TJ; Dixon JM; Stuart M; Sahmoud T; Miller WR
TI -
Effect of neoadjuvant treatment with anastrozole on tumour histology in
postmenopausal women with large operable breast cancer.
SO - Br J Cancer 2002 Jul 29;87(3):334-8
AD - Department of Pathology, Western General Hospital, Edinburgh EH4 2XU,
UK.
Anastrozole is an orally active, non-steroidal aromatase inhibitor which
appears effective as neoadjuvant treatment of breast cancer.
Histological changes have been evaluated in biopsies from large,
oestrogen-receptor rich, operable breast tumours in postmenopausal women
following 12 weeks of neoadjuvant anastrozole treatment (1 mg (n=12) or
10 mg (n=11)). Of the 23 patients, 18 had a clinical response following
treatment. Compared with pre-treatment biopsies anastrozole-treated
specimens displayed decreased cellularity and/or increased fibrosis in
15 tumours; changes in gland formation, nuclear pleomorphism, or
mitoses, in 12 cases; and a reduction in Mib1 score in all tumours.
Marked changes in apoptotic scores were seen following treatment but the
direction of effect was inconsistent. In all 17 tumours which were
positive for progesterone receptors before therapy, treatment was
associated with reduced staining for progesterone receptors. There was
no consistent effect of treatment on oestrogen-receptor expression. It
is concluded that neoadjuvant anastrozole treatment in this patient
group has marked effects on tumour histopathology but these do not
always correlate with clinical response. Copyright 2002 Cancer Research
UK
29
UI - 12195747
AU - Andersson J; Linderholm B; Greim G; Lindh B; Lindman H; Tennvall J;
TI -
Tennvall-Nittby L; Pettersson-Skold D; Sverrisdottir A; Soderberg M;
Klaar S; Bergh J
A population-based study on the first forty-eight breast cancer patients
receiving trastuzumab (Herceptin) on a named patient basis in Sweden.
SO - Acta Oncol 2002;41(3):276-81
AD - Department of Oncology, Radiumhemmet, Karolinska Institute and Hospital,
SE-171 76 Stockholm, Sweden. jenny.andersson@cck.ki.se
Several studies have presented data on the efficacy and tolerability of
trastuzumab within clinical trials. As a minority of patients is
included in these trials, we undertook this retrospective study to
describe trastuzumab therapy in clinical routine and its tolerability.
We reviewed the medical records of the first 48 patients in Sweden who
received treatment with trastuzumab on a named patient basis with (n =
29) and without (n = 19) chemotherapy. Forty-six patients had metastatic
disease and had failed to respond to several prior regimens before
starting antibody treatment. Two patients had locally advanced breast
cancer failing on given neoadjuvant therapy. Patients with breast
cancers with strong (3+) c-erbB-2 overexpression tended to have an
improved survival from start of trastuzumab treatment versus those with
a moderate (2+) overexpression (p = 0.09). Adverse events were
registered in 22 patients (46%). The most common and acute side effects
were fever and chills (7 patients, 15%). The toxicity seemed reasonable
but two patients (4%) suffered serious cardiac events, both of them
having received previous treatment with antracyclines.
30
UI - 7848882
AU - Valagussa P; Moliterni A; Terenziani M; Zambetti M; Bonadonna G
TI -
Second malignancies following CMF-based adjuvant chemotherapy in
resectable breast cancer.
SO - Ann Oncol 1994 Nov;5(9):803-8
AD - Division of Medical Oncology, Istituto Nazionale Tumori, Milan, Italy.
BACKGROUND: Only a few studies have evaluated the long-term effects of
adjuvant chemotherapy for breast cancer. Furthermore, neither the
relation between the risk of second malignancies and type of adjuvant
regimen utilized nor the interaction between chemotherapy and breast
irradiation or age of the patients have been described in detail.
METHODS: A total of 2,465 patients entered into prospective studies of
CMF-based adjuvant chemotherapy carried out at the Milan Cancer
follow-up was 12.0 years and detailed information about therapy was
available for all patients. RESULTS: At 15 years, the cumulative
actuarial risk of second malignancies (excluding contralateral breast
cancer and basal skin cancer) was 6.7% +/- 0.8% for the total series.
The figures were 8.4% +/- 2.9% after local-regional treatment alone,
6.4% +/- 0.9% following CMF, and 5.1% +/- 1.0% following CMF plus
Adriamycin (doxorubicin; Farmitalia-Carlo Erba, Milan, Italy). Compared
to the general female population, the relative risk following CMF-based
adjuvant chemotherapy was 1.29. Three patients, all of whom had received
CMF-based chemotherapy, developed acute non-lymphocytic leukemia
(cumulative risk 0.23% +/- 0.15%; relative risk 2.3). No differences
were evident when breast irradiation was considered, but the cumulative
risk of second tumors was slightly higher in women aged > or = 50 years
at surgery (7.7% +/- 1.3%) than in younger patients (6.0% +/- 1.0%).
CONCLUSIONS: At present, there is no evidence of a significantly
increased risk of second malignancies following adjuvant CMF-based
chemotherapy such as the one given in this case series. A low risk of
acute leukemia was associated with the cumulative total dose of
cyclophosphamide administered, and breast irradiation did not enhance
this risk. IMPLICATIONS: Our findings suggest that there is no reason to
omit alkylating agents from short-term effective adjuvant chemotherapy.
31
UI - 12187169
AU - Warren JL; Harlan LC; Fahey A; Virnig BA; Freeman JL; Klabunde CN;
TI -
Cooper GS; Knopf KB
Utility of the SEER-Medicare data to identify chemotherapy use.
SO - Med Care 2002 Aug;40(8 Suppl):IV-55-61
AD - Applied Research Program, National Cancer Institute, Bethesda, Maryland
20892-7344, USA.joan_warren@nih.gov
BACKGROUND: Medicare claims include codes for chemotherapy
administration and specific drugs given, and researchers are
increasingly using these data to measure the use of chemotherapy.
However, the validity and completeness of these data as a source of
information has not been established. OBJECTIVES: This analysis is
intended to assess the utility of the Medicare claims to capture
chemotherapy use. METHODS: Persons with breast, colorectal, and ovarian
cancer were identified from the linked SEER-Medicare data. Their
Medicare claims were reviewed to determine if there were any bills for
chemotherapy, and if so, if there were claims for specific agents. This
information was compared with data on the first course of treatment
obtained from hospitals and treating physicians by the SEER registries
through an NCI-supported Patterns of Care Studies (POC). Agreement was
measured using kappa statistics. The sensitivity of the Medicare claims
to capture chemotherapy, as reported from the POC data, was also
measured. An additional comparison assessed the agreement between the
two data sources concerning which specific drugs had been given.
RESULTS: For all of the cancers, there was a high level of agreement
between the Medicare claims and the POC data regarding whether or not
the patient had received chemotherapy (kappa >or=0.73). The sensitivity
of the Medicare data to determine if a person had received chemotherapy
was high (>or=88%). In cases where the Medicare claim included a code
for a specific drug, there high agreement between Medicare and POC about
the specific drug given in breast and colorectal cancers, although the
agreement was lower for ovarian cancers. The sensitivity of the Medicare
claims to identify specific agents varies by cancer type. CONCLUSIONS:
The Medicare claims can be used to identify which persons are receiving
chemotherapy. The utility of Medicare data to measure treatment with
specific agents varies by cancer type and specific agent. For some
cancers, it is possible to use these claims to assess use of specific
drugs, while for other drugs the data are limited.
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