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Abramson Cancer CenterNCI CANCERLIT® Search: Therapy of Colorectal Cancer - October 2001
National Cancer Institute®
Last Modified: November 21, 2001
Table of Contents
1
UI - 20138879
AU - Sasaki K; Nozaki M; Kikutchi Y; Yamaki T; Soejima K
TI -
Reconstruction of perianal skin defect using a V-Y advancement of
bilateral gluteus maximus musculocutaneous flaps: reconstruction
considering anal cleft and anal function.
SO - Br J Plast Surg 1999 Sep;52(6):471-5
AD - Department of Plastic and Reconstructive Surgery, Tokyo Women's Medical
College, Japan.
In order to preserve the anal function after ano-perianal skin excision
for malignancy, we have reconstructed a deep, symmetrical natal cleft
using a V-Y advancement of bilateral gluteus maximus musculocutaneous
flaps thinned medially and sutured to the ooccyx, anococcygeal ligament
and the central tendon of the perineum. This technique was applied in
three cases of Bowen's disease and two cases of Paget's disease. In all
five cases, postoperative anal functions such as comfortable defecation
and sensation, were well preserved, the perianal skin and underwear
stayed clean, and there was no disturbance of walking or exercise.
2
UI - 21245394
AU - Khayat D; Gil-Delgado M; Antoine EC; Nizri D; Bastian G
TI -
The role of irinotecan and oxaliplatin in the treatment of advanced
colorectal cancer.
SO - Oncology (Huntingt) 2001 Apr;15(4):415-29; discussion 429-30, 433-4
AD - Pharmacokinetic Laboratory of Department of Medical Oncology Hopital de
La Salpetriere Paris, France.
Colorectal carcinoma is one of the most common malignancies in the
western world, and although fluorouracil (5-FU) has been used in its
treatment for almost 40 years, new agents with significant activity have
been introduced recently. Irinotecan (CPT-11, Camptosar), a
topoisomerase I inhibitor, administered at 300 to 350 mg/m2 every 3
weeks is significantly more active than continuous-infusion 5-FU in
patients who have experienced disease progression after conventional
therapy with 5-FU. In comparison to best supportive care, irinotecan
improves survival and preserves quality of life despite
treatment-related toxicity. Moreover, the combination of irinotecan and
5-FU has been explored in a number of different schedules. In previously
untreated patients, overall response rates are high. Irinotecan can also
be combined with mitomycin (mitomycin-C [Mutamycin]), oxaliplatin, or
raltitrexed (Tomudex). Oxaliplatin is a new-generation platinum compound
that has demonstrated activity against colorectal carcinoma in
preclinical trials. It has been evaluated as a single agent against
advanced colorectal carcinoma in the salvage setting and also in
combination with 5-FU as initial therapy for metastatic disease (where
it shows significant activity). The toxicity profile of oxaliplatin
(chiefly characterized by neurotoxicity) differs from that of irinotecan
(primarily producing diarrhea) and the potential, therefore, exists for
combining these agents or for exploiting their possible synergy with
5-FU. The introduction of these two new active agents of different
pharmacologic classes promises to enable significant improvements in the
treatment of patients with colorectal carcinoma.
3
UI - 21245399
AU - Wagman RT; Minsky BD
TI -
Conservative management of rectal cancer with local excision and
adjuvant therapy.
SO - Oncology (Huntingt) 2001 Apr;15(4):513-9, 524;discussion 524-8
AD - Department of Radiation Oncology, Memorial Sloan-Kettering Cancer
Center, New York, USA.
The standard surgical treatment of distal, resectable, invasive rectal
cancers is an abdominoperineal resection or a low anterior resection.
Given the morbidity associated with these standard treatments and the
frequent need for postoperative adjuvant therapy, the use of a more
conservative approach, such as local excision with adjuvant therapy as
primary therapy for selected cases of rectal cancer is appealing. Data
from single-institution series as well as recent data from prospective,
multi-institutional studies, suggest that local excision with adjuvant
therapy is a reasonable alternative to radical surgery in selected
patients. Local excision alone is acceptable treatment only for T1
tumors without adverse pathologic features, while local excision with
adjuvant therapy is an alternative treatment for T1 tumors with adverse
pathologic features and T2 tumors. Some series suggest that preoperative
therapy with local excision may be a possible treatment for selected T3
tumors; however, the high local failure rates seen in T3 tumors treated
with local excision and postoperative therapy cautions against this
approach. Functional results with local excision are generally good, and
postoperative morbidity and mortality is acceptable. In summary, the
results of local excision and radiation therapy are encouraging.
Randomized trials are needed to determine whether this approach has
local control and survival rates comparable to those of radical surgery.
4
UI - 21243490
AU - Ngan SY
TI -
Optimising treatment for resectable rectal cancer: is preoperative
therapy beneficial?
SO - Drugs Aging 2001;18(2):79-85
AD - Peter MacCallum Cancer Institute, Melbourne, Victoria, Australia.
Preoperative radiotherapy is becoming the standard of care for
resectable locally advanced adenocarcinoma of the rectum. Its practice
is no longer limited to a few specialised cancer centres. Adjuvant
preoperative radiotherapy can reduce the risk of local recurrence by 50%
compared with surgery alone and it has a moderate effect in improving
survival. Treatment-related toxicity is superior to that after
postoperative radiotherapy. Early results of preoperative radiotherapy
with concurrent chemotherapy are promising, with a low toxicity profile
and a high pathological response rate. Advances in technology,
endorectal ultrasound and magnetic resonance imaging enable selection of
appropriate patients for preoperative radiotherapy.
5
UI - 21254747
AU - Wang WS; Lin JK; Lin TC; Chiou TJ; Liu JH; Fan FS; Yen CC; Chen WS;
TI -
Jiang JK; Yang SH; Wang HS; Chen PM
Carcinoembryonic antigen in monitoring of response to systemic
chemotherapy in patients with metastatic colorectal cancer.
SO - Int J Colorectal Dis 2001 Apr;16(2):96-101
AD - Division of Medical Oncology, Department of Medicine, Veterans General
Hospital Taipei and National Yang-Ming University School of Medicine,
Taipei 11217, Taiwan.
The response to chemotherapy of solid tumors is generally assessed by
measuring tumors visualized by imaging. However, the response assessment
based on imaging is not always feasible because patients often have
disease not measurable by imaging, such as diffuse peritoneal
dissemination. We evaluated the correlation between the change on
imaging and change in CEA levels for assessing chemotherapeutic response
colorectal carcinoma, all of whom had measurable lesions. Forty patients
received oral tegafur-uracil (300 mg/m2/day) plus folinic acid (60
mg/day) for 4 weeks, repeated every 5 weeks, as the firstline treatment.
Another 96 patients received either a weekly intravenous bolus injection
of 5-fluorouracil (400 mg/m2) plus folinic acid (20 mg/m2), or an
intravenous bolus injection of 5-fluorouracil (425 mg/m2) plus folinic
acid (20 mg/m2) for 5 consecutive days every month. Responders, based on
CEA assessment, were defined as those with a greater than 50% drop in
CEA level for more than 4 weeks. The pretreatment CEA levels were
elevated beyond the normal cutoff value in 110 (81%) patients. A
response rate of 18.4% (95% CI, 11.9-24.9%), including 8 complete
remissions and 17 partial remissions, was achieved according to imaging
studies. The response rate assessed by CEA was 25% (34/136). Sixteen
responders (47%) based on CEA had no remission on imaging. The
sensitivity of change in CEA levels in the prediction of true responders
and progressive diseases on imaging were 72% and 81%, respectively. In
terms of the positive predictive value, change in CEA levels in the
prediction of true responders and progressive disease on imaging were
53% and 85%, respectively. Patients with remarkable falls on CEA levels
survived significantly longer than nonresponders (P < 0.001, log-rank
test). At follow-up of 48 months the median survival for responders and
nonresponders assessed by CEA was 28 months and 13 months, respectively.
These data suggest that measurement of CEA levels might be helpful in
monitoring chemotherapeutic response when imaging study is unsuitable
for assessing the response in clinical practice. Furthermore,
measurement of CEA levels may be helpful in determining the prognosis of
patients with metastatic colorectal cancer receiving chemotherapy.
6
UI - 21271574
AU - Ooi BS; Eu KW; Seow-Choen F
TI -
Primary anorectal malignant melanoma: clinical features and results of
surgical therapy in Singapore--a case series.
SO - Ann Acad Med Singapore 2001 Mar;30(2):203-5
AD - Department of Colorectal Surgery, Singapore General Hospital, 1 Hospital
Drive, Singapore 169608.
INTRODUCTION: Primary malignant melanoma arising from the anorectum is
uncommon. The natural history of anorectal malignant melanoma is that of
a very poor prognosis with early dissemination of disease. Successful
surgical treatment has been rare. The present series reviews the
clinical features and results of surgical management of patients with
anorectal malignant melanoma treated in the Department of Colorectal
Surgery, Singapore General Hospital. MATERIALS AND METHODS: Data for all
patients treated for anorectal malignant melanoma during an 11-year
period from 1989 to 1999 were reviewed. The age, sex, presenting
symptoms, duration of symptoms prior to diagnosis, size of tumour,
extent of disease, type of surgery and length of survival were analysed.
RESULTS: Four men and 2 women, ranging in age from 31 to 81 years with
histologically proven primary anorectal malignant melanoma, were
included in the study. The most common (67%) presenting symptom was
rectal bleeding. The mean tumour size was 2.5 cm (range 1 to 5 cm). All
underwent abdomino-perineal resection. Three died of disseminated
disease within 17 months while the other 3 were still alive at the time
of this study; the longest up to 6.5 years from the time of diagnosis.
CONCLUSION: The prognosis of primary anorectal malignant melanoma is
poor. However, it is worthwhile treating aggressively as long-term
survivor may be encountered in some.
7
UI - 21375555
AU - Bondar' GV; Ladur AI; Psaras GG
TI -
[Radical combined colonic resection for cancer recurrence]
SO - Klin Khir 2001 Mar;(3):53-5
Experience of reoperative radical combined colonic resection for colonic
cancer in 9 patients was presented. There were no complications, nor
mortality. The preoperative radiation therapy and chemotherapy
conduction had permitted to create an optimal conditions for the
surgical intervention performance, which promoted the patients life span
increase and improved its quality significantly.
8
UI - 21338536
AU - Nakamura T; Ohno M; Tabuchi Y; Kamigaki T; Fujii H; Yamagishi H; Kuroda
TI -
Y; Kansai Carmofur Study Group
Optimal duration of oral adjuvant chemotherapy with Carmofur in the
colorectal cancer patients: the Kansai Carmofur Study Group trial III.
SO - Int J Oncol 2001 Aug;19(2):291-8
AD - First Department of Surgery, Kobe University School of Medicine, 7-5-2
Kusunkoki-cho, Chuo-ku, Kobe 650-0017, Japan. takeshi@med.kobe-u.ac.jp
A multi-institutional study was performed to evaluate the appropriate
duration of oral administration of Carmofur
(1-hexylcarbamoyl-5-fluorouracil, HCFU), a 5-fluorouracil (5-FU)
derivative, for postoperative adjuvant chemotherapy in patients with
colorectal cancer undergoing curative operation. Patients were divided
into two: i) short duration group receiving 6 months of HCFU
administration and ii) long duration group receiving 1 year of the
administration, using a centralized registration system. Among 364
patients entered in this study, 293 evaluable cases were analyzed to
investigate the appropriate duration of adjuvant oral chemotherapy. No
statistical differences were found in the cumulative 5-year disease-free
or survival rates between the groups. However, the actual duration of
oral HCFU administration differed in the patients of short and long
duration groups from the protocol. Namely, more than 70% of the patients
received a different duration of oral adjuvant chemotherapy in each of
the groups. Therefore, apart from this division of two groups,
correlation between the actual duration of oral HCFU administration and
the prognosis was examined in these patients. As a result, it was
suggested that oral adjuvant chemotherapy with HCFU would be effective
in colon cancer patients when the duration of administration exceeded
330 days. In rectal cancer patients, however, adjuvant chemotherapy with
HCFU alone was considered to be not sufficient to affect the prognosis.
9
UI - 21338544
AU - Uchida K; Hayashi K; Kuramochi H; Takasaki K
TI -
Changes in intratumoral thymidylate synthase (TS) and dihydropyrimidine
dehydrogenase (DPD) mRNA expression in colorectal and gastric cancer
during continuous tegafur infusion.
SO - Int J Oncol 2001 Aug;19(2):341-6
AD - Department of Surgery, Institute of Gastroenterology, Tokyo Women's
Medical University, 8-1 Kawadachou, Shinjuku-ku, Tokyo 162-8666, Japan.
Thymidylate synthase (TS) is the target enzyme of 5-fluorouracil (5-FU),
and dihydropyrimidine dehydrogenase (DPD) is the key enzyme in the 5-FU
catabolic pathway. We wanted to determine whether the TS and DPD mRNA
expression levels of gastric and colorectal cancer patients would be
affected by tegafur (futrafur:FT)-based chemotherapy and whether changes
in their expression might be responsible for patient outcome.
Thirty-five patients with resectable advanced primary gastric cancer and
36 patients with resectable advanced primary colorectal cancer were the
subjects of this study. They all underwent neoadjuvant chemotherapy with
protracted infusion of FT alone or FT plus low doses of cisplatin. The
TS and DPD mRNA expression levels of endoscopic biopsy specimens before
chemotherapy and surgical specimens after chemotherapy were measured by
TaqMan reverse transcription-PCR assay using glyceraldehyde-3-phosphate
dehydrogenase (GAPDH) as the internal standard. There was a significant
difference in the DPD mRNA levels during chemotherapy in the colorectal
cancers. Although the TS and DPD levels were unrelated to any
conventional histopathological grade factors, colorectal cancer patients
whose surgical specimens contained lower TS and DPD mRNA levels had
longer disease-free intervals. The results of this study suggest that FT
may affect DPD mRNA expression in colorectal cancer patients, that
TS/DPD expression can be regarded as an independent prognostic factor,
and that colorectal cancer patients with low TS and low DPD mRNA are
candidates for FT-based adjuvant chemotherapy. In addition, quantitative
analysis of the change in TS/DPD mRNA in surgical specimens during
FT-based chemotherapy might be a more accurate means of predicting the
post-operative disease-free interval of colorectal cancer patients than
analysis of endoscopic specimens before chemotherapy. There also seems
to be a relation between regulation of TS and DPD during FT
chemotherapy. Elucidation of the mechanisms regulating TS and DPD mRNA
expression might make it possible to predict sensitivity and/or toxicity
to FT.
10
UI - 21403178
AU - Liu J; Kolar C; Lawson TA; Gmeiner WH
TI -
Targeted drug delivery to chemoresistant cells: folic acid
derivatization of FdUMP[10] enhances cytotoxicity toward 5-FU-resistant
human colorectal tumor cells.
SO - J Org Chem 2001 Aug 24;66(17):5655-63
AD - Eppley Institute, University of Nebraska Medical Center, Omaha, Nebraska
68198-6805, USA.
Current chemotherapy protocols that include fluoropyrimidines, such as
5-fluorouracil (5-FU), are limited by the development of chemoresistance
during the course of treatment. Our laboratory has developed a novel
class of fluoropyrimidines, FdUMP[N], that are oligodeoxynucleotides
(ODNs) composed of some number, N, of
5-fluoro-2'-deoxyuridine-5'-O-monphosphate (FdUMP) nucleotides. Novel
synthetic procedures are described that permit conjugation of folic acid
to the 5'-OH of FdUMP[10] via a phosphodiester linkage using automated
synthesis. The synthetic methods developed are generally applicable for
ODN conjugation with folic acid. The folic acid conjugate FA-FdUMP[10]
showed improved cytotoxicity toward human colorectal tumor cells (H630),
and 5-FU-resistant colorectal tumor cells (H630-10). Enhanced
cytotoxicity was observed for FA-FdUMP[10] relative to nonconjugated
FdUMP[10] for cells grown under folate-restricted conditions, consistent
with cellular uptake being, in part, receptor-mediated. Folate receptor
alpha (FRalpha) mRNA was shown by RT-PCR to be overexpressed 26.3-fold
in 5-FU-resistant H630-10 cells relative to H630 cells. Thus,
FA-FdUMP[N] may prove useful for the treatment of 5-FU-resistant
malignancies.
11
UI - 21443831
AU - Stocchi L; Nelson H; Sargent DJ; O'Connell MJ; Tepper JE; Krook JE;
TI -
Beart R Jr; North Central Cancer Treatment Group
Impact of surgical and pathologic variables in rectal cancer: a United
States community and cooperative group report.
SO - J Clin Oncol 2001 Sep 15;19(18):3895-902
AD - Division of Colon and Rectal Surgery, Cancer Center Statistics Unit,
Mayo Clinic and Mayo Foundation, Rochester, MN 55905, USA.
PURPOSE: Substantial and successful effort has been focused on
decreasing the risk of local failure after rectal cancer surgery through
the use of adjuvant therapies. Our study examined data from studies
conducted by United States cooperative groups to investigate the impact
of surgical and pathologic variables in rectal cancer outcomes. PATIENTS
AND METHODS: Surgical and pathologic reports from 673 patients with
stage II/III rectal cancer enrolled onto three adjuvant clinical trials
were reviewed for tumor and surgical variables. Additional information
on individual institutions and operating surgeon was collected.
Variables were tested for association with 5-year local recurrence and
survival after adjustment for adjuvant treatments and other important
prognostic factors. RESULTS: Five-year local recurrence and survival
rates were 16% and 59%, respectively. Surgeons treating more than 10
study cases had lower local recurrence rates than those treating < or =
10 (11% v 17%, P =.02). Free radial margins also correlated with local
recurrence (P =.01). Type of surgery, distal margins, and tumor radial
spread were not significant. Tumor adherence to adjacent structures
predicted local recurrence (35% v 14%, P <.001) and survival (30% v 63%,
P <.001), regardless of en bloc resection. Although T and N
classification predicted survival (P <.001), only N classification
correlated with local recurrence. The number and percentage of positive
nodes correlated with survival, but only the percentage independently
predicted local recurrence. Several pathologic and surgical variables
were reported suboptimally. CONCLUSION: Moderate variability in outcomes
among surgeons was detected in this high-risk population. Efforts to
improve surgical results will require changes in reporting practices to
allow for more accurate assessment of the quality of surgery.
12
UI - 21443833
AU - Kalemkerian GP
TI -
"But doctor, what have I got to lose...?".
SO - J Clin Oncol 2001 Sep 15;19(18):3904
13
UI - 21452843
AU - Andre T; Louvet C; Maindrault-Goebel F; Gramont AD
TI -
[Oxaliplatin in combination with 5-fluoro-uracil and folinic acid as
treatment of metastatic colorectal cancer]
SO - Bull Cancer 2001 Aug;88 Spec No():S20-5
AD - Hopital Tenon, 4, rue de la Chine, 75020 Paris, France.
Unusual aspect of the development of oxaliplatin was that substantial
evidence of its activity was gathered when used in combination with
protracted infusion of 5FU combined with leucovorin, preceeding the
formal demonstration of its single activity in this disease. Phase II
trials in previously treated patients by 5FU, have shown response rate
of 10% with oxaliplatin in monotherapy and 18,4 to 58% with
chronomodulated or bimonthly regimen combining oxaliplatin, 5FU and
leucovorin. These trials have confirmed additive or synergistic
antitumoral effects of this combination. Dose intensity of oxaliplatin
may be important in determining the efficacy of the triple agent
regimen. For previously untreated patients, Folfox4 (LV5FU2 + 85 mg/m2
of oxaliplatin) and chronomodulated regimen have obtained objective
response rate ranged from 51 to 66%, with progression-free survival
between 8.2 and 11 months and overall survival from 16 to 19 months. A
better use of oxaliplatin in combination with 5FU and leucovorin may
decrease the dose-limiting toxicity, i.e. the usually transient sensory
neurotoxicity. Patients with initially unresectable metastases treated
with this three-drug combination could sometimes underwent complete
metastases surgery. Several studies are currently in progress either to
confirm the high activity of the LV5FU-oxaliplatin combination or to
define a strategy based on the best sequence or the best combinations
with the other available drugs, irinotecan and raltitrexed.
14
UI - 21452845
AU - Ducreux M; Fizazi K; Seitz JF; Becouarn Y; Armand JP
TI -
[Oxaliplatin in combination with non fluoropyrimidine drugs in
colorectal cancer]
SO - Bull Cancer 2001 Aug;88 Spec No():S35-9
AD - Unite de gastroenterologie, Institut Gustave-Roussy, rue
Camille-Desmoulins, 94805 Villejuif Cedex.
After decades of exclusive use of fluorouracil in the treatment of
metastatic colorectal cancer, three new drugs, among them oxaliplatin,
have recently shown interesting results. Oxaliplatin has an activity
when it is given alone but this drug is particularly interesting for
combination chemotherapy because it has a favourable toxicity profile
without important haematologic or digestive toxicities and because it
has a convenient schedule of administration (short infusion every two or
three weeks). Phases I and II studies have demonstrated the feasibility
of the combination of raltitrexed and oxaliplatin. A recent phase II
study has evaluated the efficacy of this new combination in 71 non
pre-treated patients. The observed response rate was high: 59.5%. The
combination of oxaliplatin and irinotecan has been assessed in three
phase I studies (two with a three-weekly schedule and the last one with
a biweekly schedule). These studies have determined the doses which
could be used in further phase II studies, these doses were close to the
doses used in monotherapy. Results of the efficacy of the three-weekly
schedule are available only in second line therapy, with 42% of
objective response rate in 36 patients. The dose intensity was
maintained with the use of hematopoietic growth factors. These new
combinations with oxaliplatin give us the opportunity to treat the
patient with schedules excluding fluorouracil which has a variable
metabolism.
15
UI - 21452847
AU - Bugat R
TI -
[Oxaliplatin tolerance in the treatment of metastatic colorectal
cancers]
SO - Bull Cancer 2001 Aug;88 Spec No():S45-9
AD - Institut Claudius-Regaud, 20-24, rue du Pont-Saint-Pierre, 31052
Toulouse.
Oxaliplatin is a new platinum compound with a 1,2-diaminocyclohexane
(DACH) carrier ligand. It has recently been developed in metastatic
colorectal cancer treatment, where it is generally combined with 5FU and
leucovorin. Safety data in this indication concern over 1,700 patients,
who received 12,500 cycles during clinical trials. Oxaliplatin appears
to be relatively well tolerated and easy to handle, even on an
outpatient basis. Gastrointestinal toxicity is common, but controllable
and rarely severe or long-lasting. Haematological and mucosal tolerance
is satisfactory, and oxaliplatin does not seem to have renal toxicity.
Neurological side effects are the drug's limiting toxicity and can
present as acute neurotoxicity (dysesthesiae), which is rapidly
reversible, or sometimes as a longer-lasting effect, correlated in this
case with the cumulative dose and leading to functional impairment in 10
to 20% of patients after 6 cycles or more. Neurological symptoms improve
in the vast majority of cases after treatment is stopped. In this
situation, it is even possible to restart oxaliplatin treatment. Good
patient information and dose adjustments should allow us to manage the
majority of neurological toxicity associated with oxaliplatin
administration.
16
UI - 21452841
AU - Laadem A; Cvitkovic E
TI -
[Oxaliplatin: a first DACH-platinum in oncology]
SO - Bull Cancer 2001 Aug;88 Spec No():S9-13
AD - 18-20, rue Pasteur, 94278 Kremlin-Bicetre Cedex.
Around 3,000 cisplatin analogues have been synthetised over the past 30
years but only half a dozen are presently in clinical development, while
only two (cisplatin and carboplatin) have been available prior to the
recent European registration of oxaliplatin. Oxaliplatin is a new
platinum salt belonging to the DACH (diaminocyclohexane) platinum
family, and is the only such cisplatin analogue that has entered
clinical development and achieved approval for marketing. During its
development, oxaliplatin has aroused lively interest due, firstly, to
its in vitro and in vivo antitumoral activity, especially in
cisplatin-resistant models and cell lines expressing resistance genes,
and, secondly, to its good clinical tolerance, the absence of renal or
auditory toxicity being combined with a low hematotoxicity. Combined
with other antitumoral agent cytotoxic agents (5FU, raltitrexed,
irinotecan or cisplatin), oxaliplatin produces an additive and often
synergistic cytotoxic effect. The oxaliplatin-5FU +/- FA combination is
now well established in metastatic colorectal cancer. Regarding its
particular cytotoxic characteristics and its activity in mismatch repair
deficient cells (which are resistant to cisplatin and carboplatin),
oxaliplatin is shows potential in a large variety of solid tumor types,
notably in association with other cytotoxic agents, thus opening the
path to a wider range of indications.
17
UI - 21468604
AU - Bensmaine; de Gramont A; Brienza S; Marty M; Levi F; Ducreux M; Francois
TI -
E; Gamelin E; Bleiberg H; Bleuzen P; Simon J; Cvitkovic E
Factors predicting for efficacy of oxaliplatin in combination with
5-fluorouracil (5-FU)+/-folinic acid (FA) in a compassionate-use cohort
of 370 5-FU-resistant advanced colorectal cancer (CRC) patients.
SO - Eur J Cancer 2000 Dec;36(18):2335-43
AD - Cvitkovic and Associates, Kremlin-Bicetre, France.
Univariate and multivariate analyses were performed on data from 370
5-fluorouracil (5-FU)-resistant advanced colorectal cancer patients
treated with oxaliplatin (Eloxatin)/5-FU+/-folinic acid (FA) to identify
prognostic factors for oxaliplatin-based treatment. The response rate
was 14.6% (95% confidence interval (CI): 11.0-18.2%), median time to
progression was 4.3 months (95% CI: 3.9-4.7), and median overall
survival 9.7 months (95% CI: 8.5-10.8). Multivariate analysis indicated
< 2 prior chemotherapy regimens, bi-weekly treatment administration
schedule (versus tri-weekly) and continuous chronomodulated delivery
(CCM) as significantly associated (P < 0.05) with a higher overall
response rate. Performance status (PS) < 2, having only one involved
organ, biweekly schedule and CCM were associated (P < 0.05) with a
longer time to progression. Good PS, one involved organ, low alkaline
phosphatase (AP) serum levels, bi-weekly schedule and CCM were
significantly correlated with longer overall survival, while confirming
the efficacy of oxaliplatin/5-FU+/-FA in this indication.
18
UI - 21190904
AU - Damle B; Ravandi F; Kaul S; Sonnichsen D; Ferreira I; Brooks D; Stewart
TI -
D; Alberts D; Pazdur R
Effect of food on the oral bioavailability of UFT and leucovorin in
cancer patients.
SO - Clin Cancer Res 2001 Mar;7(3):517-23
AD - Department of Metabolism and Pharmacokinetics, Bristol-Myers Squibb
Pharmaceutical Research Institute, Princeton and Hopewell, New Jersey
08543, USA. bharat.damle@bms.com
UFT is composed of tegafur (FT), a prodrug of 5-fluorouracil (5-FU), and
uracil in a fixed combination (1:4). In conjunction with leucovorin, UFT
is being developed for the first-line oral treatment of metastatic
colorectal cancer. The effect of food on the oral bioavailability of UFT
(2 x 100 mg capsules; dose in terms of FT) and leucovorin (2 x 15 mg
tablets) was evaluated in a single-dose, randomized, two-way crossover
study. Patients (n = 25) were assigned to receive both drugs after an
overnight fast or 5 min after completion of a high-fat meal (721
calories) with a 3-day washout period between treatments; then they were
permitted to continue on oral UFT/leucovorin therapy for safety
assessment. UFT (300 mg/m2/day as three divided doses) and leucovorin
(90 mg/day as three divided doses) were given for 28 days. After a 7-day
rest, the 28-day cycle was repeated. Pharmacokinetics (n = 22 patients)
were determined for FT, 5-FU, uracil, leucovorin, and
5-methyltetrahydrofolate (an active metabolite of leucovorin). The
absence of food-effect on peak plasma concentration (CMAX) and the area
under the curve (AUC) was concluded if the 90% confidence interval for
the ratio of the treatment means was entirely contained in 0.75-1.33.
Administration of UFT with food resulted in a 34% decrease in CMAX of
FT, whereas the AUC of FT remained unchanged. Food decreased the CMAX
and AUC values of uracil and 5-FU by 37-76%. On the contrary, the CMAX
and AUC values of leucovorin and 5-methyltetrahydrofolate were increased
by 14-60% with food. Time to reach CMAX for all analytes was
significantly (P < or = 0.001) delayed by food. Except for the AUCs of
FT, the statistical criterion for concluding a lack of food-effect was
not met. These data suggest that UFT/leucovorin should not be dosed
simultaneously with food. It is recommended that food should not be
consumed for 1 h before and after an oral dose of UFT and leucovorin in
a manner similar to pivotal Phase III trials. The 28-day oral regimen of
UFT and leucovorin was generally well tolerated in the population
studied.
19
UI - 21271455
AU - Rains N; Cannan RJ; Chen W; Stubbs RS
TI -
Development of a dendritic cell (DC)-based vaccine for patients with
advanced colorectal cancer.
SO - Hepatogastroenterology 2001 Mar-Apr;48(38):347-51
AD - Wakefield Gastroenterology Centre and Research Institute, Wellington,
New Zealand.
BACKGROUND/AIMS: An ability to induce a specific immune response to
cancer would provide an important new dimension in its management. We
report our initial work investigating the safety and efficacy of a
dendritic cell vaccine in patients with colorectal cancer. METHODOLOGY:
Fifteen (15) patients with advanced colorectal cancer had vaccines
prepared from autologous dendritic cells pulsed with tumor RNA and
keyhole limpet hemocyanin. Vaccines were administered intravenously and
patients were observed in hospital for 2 days. Thereafter, consultations
were at monthly intervals at which time booster doses were given to a
total of 4. Patients were monitored with weekly blood tests, including
carcinoembryonic antigen, and 3-monthly computed tomography scans.
RESULTS: Flow cytometry confirmed dendritic cell phenotype and in vitro
function was confirmed by mixed lymphocyte reaction. No major adverse
effects were observed. Eleven of 13 patients tested developed a positive
keyhole limpet hemocyanin skin test and in 7 the carcinoembryonic
antigen fell suggesting some in vivo anticancer effect. To date no
dramatic clinical responses have been observed but follow-up is very
short. CONCLUSIONS: The therapy was well tolerated. Dendritic cells were
verified by phenotype and in vitro function. The positive keyhole limpet
hemocyanin skin test confirms in vivo function by effective vaccination
to keyhole limpet hemocyanin. Demonstration of any anticancer efficacy
will require further follow-up.
20
UI - 21271476
AU - Chiappa A; Zbar AP; Bertani E; Biella F; Audisio RA; Staudacher C
TI -
Surgical outcomes for colorectal cancer patients including the elderly.
SO - Hepatogastroenterology 2001 Mar-Apr;48(38):440-4
AD - Department of Emergency Surgery, Surgical Oncology, University of Milan,
S. Raffaele Scientific Institute, Milan, Italy. antonio.chiappa@unimi.it
BACKGROUND/AIMS: The aim of this study was to compare the short- and
long-term outcome of older and younger colorectal cancer patients
resected for cure. METHODOLOGY: Three hundred and forty-six consecutive
colorectal cancer patients who underwent some form of surgery were
analyzed. One hundred and forty-four patients were < 65 years old (group
1), 151 patients were 65-79 years old (group 2), and 51 patients were 80
years or more (group 3). RESULTS: The overall perioperative mortality
rate was 1.7% (n = 6). The median length of hospital stay was 19 days
(range: 3-86 days). By univariate analysis, intraoperative bleeding (500
mL or more) (P = 0.009), duration of operations (240 min or more) (P =
0.03), and the presence of rectal cancer (P = 0.001), were strongly
associated with higher incidence of postoperative complications. In
multiple logistic regression analysis, only rectal cancer (P = 0.02) was
significantly associated with serious postoperative complications. No
age-related difference was noted concerning 5-year cancer-specific
survival rates for patients with < 65, 65-79, and > or = 80 years who
underwent surgery for cure (85%, 76%, and 69%, respectively) (P = 0.3).
Using logistic regression analysis, tumor stage (P = 0.0001) and
perioperative blood transfusions (500 mL or more) (P = 0.05) were
strongly associated with outcome. CONCLUSIONS: Colorectal curative
surgery for malignancy can be performed safely in the elderly with
acceptable morbidity and mortality rates and long-term survival.
21
UI - 21274207
AU - Sailer M; Fein M; Fuchs KH; Bussen D; Grun C; Thiede A
TI -
Morphologic changes of the anal sphincter musculature during and after
temporary stool deviation.
SO - Langenbecks Arch Surg 2001 Apr;386(3):183-7
AD - Department of Surgery, University School of Medicine Wurzburg, Germany.
m.sailer@mail.uni-wuerzburg.de
BACKGROUND AND AIMS: Temporary stool deviation, using a stoma, is a
well-known surgical principle to protect low colorectal or coloanal
anastomoses. The purpose of this study was to evaluate any morphologic
changes with regard to the anal sphincter muscles during and after
temporary ileostomy. PATIENTS AND METHODS: Forty-four patients with
rectal carcinomas were studied prospectively. All patients underwent low
anterior resection. Reconstruction was performed using either a coloanal
pouch or a straight end-to-end anastomosis. A protective stoma was
fashioned in all 44 patients (ileostomy n=41; colostomy n=3). Stoma
closure was carried out after a median of 85 days (41-330 days). Using a
standard protocol, anal-sphincter thickness [m. puborectalis, external
anal sphincter (EAS) and internal anal (IAS) sphincter] was assessed by
means of endoanal ultrasonography preoperatively, at the time of stoma
closure, and every 3 months thereafter for 1 year. RESULTS: The diameter
of the puborectal muscle decreased from a median preoperative value of
6.3 mm to 5.7 mm at the time of stoma closure (P=0.03). After 3 months,
6.2 mm was measured. This value remained stable for the complete
follow-up period. Similar results were recorded for the EAS. The IAS
thickness remained stable throughout the study period, measuring between
2.1 mm and 2.4 mm. CONCLUSION: Temporary stool deviation does lead to
morphologic changes of the anal sphincter. While the smooth muscle
remains unchanged, the striated counterpart undergoes atrophic
transformation. However, after passage reconstruction, i.e., stoma
closure, a rapid regeneration of the voluntary muscles is observed.
22
UI - 21274209
AU - Willis S; Kasperk R; Braun J; Schumpelick V
TI -
Comparison of colonic J-pouch reconstruction and straight coloanal
anastomosis after intersphincteric rectal resection.
SO - Langenbecks Arch Surg 2001 Apr;386(3):193-9
AD - Chirurgische Universitatsklinik und Poliklinik der RWTH Aachen, Germany.
stefan.willis@post.rwth-aachen.de
The tendency towards sphincter-preserving resection for distal rectal
cancers has led to the technique of straight coloanal anastomosis (CAA)
and colonic J-pouch anal anastomosis (CPA) after low anterior resection.
The aim of the present study was to compare complication rate, anorectal
physiology and functional results after both types of reconstruction
after ultra-low intersphincteric resection. A total of 31 patients who
had undergone CPA were followed up prospectively using anorectal
manometry and a standardised questionnaire and were compared with 63
patients who had undergone CAA and were followed up in the same way. The
complication rate after CPA did not differ significantly from that after
CAA. One year postoperatively, the median stool frequency and urgency
were reduced after CPA (1.7+/-2.2/day; 7% vs. 2.4+/-3.6/day; 14%;
P<0.05). Three months after colostomy/ileostomy closure, the maximum
tolerable volume, threshold volume and compliance were decreased after
CAA when compared with CPA (55+/-12, 34+/-12, and 3.9+/-0.3 ml/mmHg vs.
85+/-21, 53+/-11 and 6.2 ml/mmHg, respectively; P<0.05). Anal manometry
revealed no significant differences in the anal resting and squeeze
pressure. One year postoperatively, continence also did not differ
significantly between CPA and CAA. Colonic J-pouch reconstruction seems
to be superior to the straight coloanal anastomosis, especially during
the first postoperative year. In view of the often poor prognosis of the
patients, it is the reconstruction of choice after ultra-low resections
of the rectum.
23
UI - 21283761
AU - Bauhofer A; Lorenz W; Stinner B; Rothmund M; Koller M; Sitter H; Celik
TI -
I; Farndon JR; Fingerhut A; Hay JM; Lefering R; Lorijn R; Nystrom PO;
Schafer H; Schein M; Solomkin J; Troidl H; Volk HD; Wittmann DH; Wyatt
J; Lucerne Group for Consensus-assisted Development of the Study
Protocol on Prevention of Abdominal Sepsis: Example G-CSF
Granulocyte-colony stimulating factor in the prevention of postoperative
infectious complications and sub-optimal recovery from operation in
patients with colorectal cancer and increased preoperative risk (ASA 3
and 4). Protocol for a controlled clinical trial developed by consensus
of an international study group. Part two: design of the study.
SO - Inflamm Res 2001 Apr;50(4):187-205
AD - Institute of Theoretical Surgery, Philipps-University Marburg, Germany.
bauhofer@mailer.uni-marburg.de
GENERAL DESIGN: Presentation of a new type of a study protocol for
evaluation of the effectiveness of an immune modifier (rhG-CSF,
filgrastim): prevention of postoperative infectious complications and of
sub-optimal recovery from operation in patients with colorectal cancer
and increased preoperative risk (ASA 3 and 4). This part describes the
design of the randomised, placebo controlled, double-blinded,
single-centre study performed at an university hospital (n = 40 patients
for each group). OBJECTIVE: The trial design includes the following
elements for a prototype protocol: * The study population is restricted
to patients with colorectal cancer, including a left sided resection and
an increased perioperative risk (ASA 3 and 4). * Patients are allocated
by random to the control or treatment group. * The double blinding
strategy of the trial is assessed by psychometric indices. * An endpoint
construct with quality of life (EORTC QLQ-C30) and a recovery index
(modified Mc Peek index) are used as primary endpoints. Qualitative
analysis of clinical relevance of the endpoints is performed by both
patients and doctors. * Statistical analysis uses an area under the
curve (AUC) model for improvement of quality of life on leaving hospital
and two and six months after operation. A confirmatory statistical model
with quality of life as the first primary endpoint in the hierarchic
test procedure is used. Expectations of patients and surgeons and the
negative affect are analysed by social psychological scales. CONCLUSION:
This study design differs from other trials on preoperative prophylaxis
and postoperative recovery, and has been developed to try a new concept
and avoid previous failures.
24
UI - 21366962
AU - Bondar' GV; Basheev VKh; Psaras GG; Zolotukhin SE; Borota AV; Efimochkin
TI -
OE
[Modern aspects of treatment of colonic cancer, complicated by ileus.
Part II. Treatment of colonic cancer, complicated by ileus]
SO - Klin Khir 2000 Sep;(9):20-1
The results of treatment of 364 patients with colonic cancer,
complicated by ileus. In 165 patients with partial ileus the radical
operative interventions were performed, palliative--in 61 and
symptomatic--in 83; with complete ileus--in 30.9 and 16 patients
accordingly. Application of the interintestinal anastomoses formation
methods, elaborated in the clinic, had permitted to perform
primarily-restorational operations in 81.9% of patients with partial
ileus and in 61.5%--with complete one, obtaining satisfactory immediate
results. Insufficiency of the duplicature anastomosis sutures had
occurred in 5 (2.2%) of colonic cancer patients, suffering partial
ileus.
25
UI - 21407978
AU - O'Mahony C; Law C; Gollnick HP; Marini M
TI -
New patient-applied therapy for anogenital warts is rated favourably by
patients.
SO - Int J STD AIDS 2001 Sep;12(9):565-70
AD - Department of Genito-Urinary Medicine, The Countess of Chester Hospital,
Countess of Chester Health Park, Liverpool Road, Chester CH2 1UL, UK.
dr.o'mahony@coch-tr.nwest.nhs.uk
Our objective was to determine patient attitudes to having genital
warts, and their perceptions of their treatment with imiquimod and other
therapies. As an adjunct to a clinical trial in which patients with
external genital warts were treated with imiquimod 5% cream until their
warts cleared or for up to 16 weeks, quantitative questionnaires
consisting of multiple choice questions and 5-point rating scales were
completed prior to, and at the end, of the study period. Pre-study and
post-study questionnaires were completed by 902 and 629 patients,
respectively. Patients expressed a definite concern about genital warts.
The majority of patients (70%) had been previously treated for genital
warts, and expressed dissatisfaction with their previous therapies. Of
patients treated with imiquimod in this study, 82% reported that their
warts decreased in size; this occurred within the first 4 weeks for 78%
of patients. Sixty-one per cent of patients perceived that their warts
completely cleared within the 16-week treatment period. Patients rated
imiquimod 5% cream as better than other genital wart therapies in terms
of overall satisfaction, time to clearance, convenience and lack of
associated pain. In conclusion, patients rated imiquimod 5% cream as an
effective treatment which clears warts in an acceptable length of time
causing minimal pain and is convenient to use.
26
UI - 21424856
AU - Baker D
TI -
Current surgical management of colorectal cancer.
SO - Nurs Clin North Am 2001 Sep;36(3):579-92, xi-xii
AD - Department of Surgery Johns Hopkins Hospital, Baltimore, Maryland 21287,
USA. dbaker@jhmi.edu
Colorectal cancer is the leading cause of death from gastrointestinal
malignancies in the United States. Recent emphasis on screening of
high-risk and no-risk individuals in addition to careful postoperative
surveillance has decreased the incidence and improved the quality of
life of survivors. Although multimodality approaches to treating
colorectal cancer are favored, surgical resection continues to be the
mainstay for a cure. This article reviews current surgical approaches
and advances based on evidence for best practice.
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