Τίτλος:
Sequential administration of 5-fluorouracil (5FU)/leucovorin (LV)
followed by irinotecan (CPT-11) at relapse versus CPT-11 followed by
5-FU/LV in advanced colorectal carcinoma - A phase III randomized study
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
Purpose: The purpose of the present study was to evaluate the
differences in the sequence of administration of 5-fluorouracil
(5-FU)/leucovorin (LV) followed by irinotecan (CPT-11), or CPT-11
followed by 5-FU/LV in advanced colorectal cancer (ACC). Patients and
Methods: Chemotherapy-naive patients with ACC were allocated to the
following treatment groups: group A, a bolus of 20 mg/m(2) LV and 425
mg/m(2) 5-FU for 5 days until progression/relapse, and upon progression
treatment with weekly CPT-11 (100 mg/m(2)), and group B, CPT-11 followed
at progression/relapse by 5-FU/LV at the same doses and schedules as in
group A. Results: 120 patients were randomized to receive one of the two
treatment sequences and their pretreatment characteristics were equally
balanced between treatment arms. No statistically significant difference
was found in the objective response rate to CPT-11 (p = 0.45); partial
response (PR) was 23.3% for group A patients and 33.3% for group B.
Following documented progression and second line treatment there was a
significant difference between the response rate in group A (23.3%) and
group B where no patients were found to respond to second-line treatment
with 5-FU/LV (p = 0.024). The median overall survival was 42.0 weeks
(range, 36.6-47.4 weeks) for group A and 32.0 weeks (range, 28.2-35.8
weeks) for group B. The median time to progression for patients in group
A following first-line 5-FU/LV was 18 weeks (range, 10-36 weeks) and 12
weeks (range, 10-16 weeks) for group B following first-line CPT-11 (p =
0.0005). Toxicity, according to WHO, was similar between groups.
Conclusions: Treating patients with CPT-11 upon progression to 5-FU/LV
treatment seems to be superior to the opposite sequence. We used these
treatments as sequential monotherapies (at progression/relapse), and the
best results are gained when 5-FU/LV is followed by CPT-11 at disease
progression or relapse. Copyright (C) 2007 S. Karger AG, Basel.
Συγγραφείς:
Tsavaris, Nicolas
Kosmas, Christos
Skopelitis, Helias and
Papadoniou, Nicitas
Polyzos, Aristidis
Zografos, George and
Adoniou, Efstathios
Gryniatsos, John
Felekouras, Evangelos and
Zacharakis, Michalis
Sigala, Francheska
Bacoyiannis, Christos
and Papastratis, George
Papalambros, Efstathios
Περιοδικό:
Antiviral Chemistry and Chemotherapy
Λέξεις-κλειδιά:
colorectal cancer; 5-fluorouracil; irinotecan; leucovorin
