Annual Meeting Proceedings Part 1 - American Society of Clinical ...

LBA4000 Oral Abstract Session, Sat, 3:00 PM-6:00 PM
A randomized, multicenter trial of epirubicin, oxaliplatin, and capecitabine
(EOC) plus panitumumab in advanced esophagogastric cancer (REAL3).
Presenting Author: Tom Samuel Waddell, Royal Marsden Hospital NHS
Foundation Trust, London, United Kingdom
The full, final text of this abstract will be available at
abstract.asco.org at 12:01 AM (EDT) on Saturday, June 2,
2012, and in the Annual Meeting Proceedings online
supplement to the June 20, 2012, issue of Journal of
Clinical Oncology. Onsite at the Meeting, this abstract will
be printed in the Saturday edition of ASCO Daily News.
4002 Oral Abstract Session, Sat, 3:00 PM-6:00 PM
Randomized phase III study of irinotecan (CPT-11) versus weekly paclitaxel
(wPTX) for advanced gastric cancer (AGC) refractory to combination
chemotherapy (CT) of fluoropyrimidine plus platinum (FP): WJOG4007
trial. Presenting Author: Shinya Ueda, Kinki University School of Medicine,
Osakasayama, Japan
Background: A combination CT of FP has been regarded as the standard
first-line treatment for AGC. Although two randomized trials showed a
survival benefit of second-line CT (CPT-11 or docetaxel) compared with
best supportive care, no standard regimen has been established. In Japan,
wPTX has been used more frequently than docetaxel as the second-line CT.
The objective of this study was to compare CPT-11 with wPTX in patients
(pts) with AGC refractory to FP. Methods: Patients with AGC refractory to the
first-line FP regimen were randomized 1:1 to either CPT-11 (150 mg/m2 ,
q2w) or wPTX (80 mg/m2 , days 1, 8, 15, q4w). The primary endpoint was
overall survival (OS) and secondary endpoints were progression-free survival
(PFS), overall response rate (ORR), adverse events and receiving rates
of third-line CT. To demonstrate an increase in median OS from 5 months
(wPTX) to 7.5 months (CPT-11) with 2-sided alpha 5% and 80% power,
220 pts were required. Results: Between Aug 2007 and Aug 2010, 223 pts
were enrolled; 112 pts were randomized to CPT-11 and 111 pts to wPTX.
Baseline characteristics were well balanced between arms. Median OS was
8.4 months for CPT-11 and 9.5 months for wPTX (HR 1.132; 95% CI,
0.86-1.49; p�0.38). Median PFS was 2.3 months for CPT-11 and 3.6
months for wPTX (HR 1.14; 95% CI, 0.88-1.49; p�0.33). The ORR was
13.6% (12/88) for CPT-11 and 20.9% (19/91) for wPTX (p�0.20). The
most common grade 3/4 adverse events were neutropenia (39.1% for
CPT-11 vs. 28.7% for wPTX), anemia (30.0% vs. 21.3%), anorexia
(17.3% vs. 7.4%) and fatigue (12.7% vs. 6.5%). Four (4%) CPT-11 and
three (3%) wPTX recipients died within 30 days after the last administration.
Subsequent CT was performed in 80 pts (71%) for CPT-11 and 97 pts
(89%) for wPTX. Seventy-five pts (67%) in the CPT-11 group and 87 pts
(80%) in the wPTX group received the crossover CT. Conclusions: The
WJOG4007 trial, the first phase III study comparing second-line CT
regimens for AGC, did not demonstrate the superiority of CPT-11 over
wPTX. Thus, wPTX can be adopted as a control arm of future phase III trials
of second-line CT for AGC.
Gastrointestinal (Noncolorectal) Cancer
239s
LBA4001 Oral Abstract Session, Sat, 3:00 PM-6:00 PM
Intergroup Trial of Adjuvant Chemotherapy in Adenocarcinoma of the
Stomach (ITACA-S) trial: Comparison of a sequential treatment with
irinotecan (CPT-11) plus 5-fluorouracil (5-FU)/folinic acid (LV) followed by
docetaxel and cisplatin versus a 5-FU/LV regimen as postoperative treatment
for radically resected gastric cancer. Presenting Author: Emilio
Bajetta, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy
The full, final text of this abstract will be available at
abstract.asco.org at 12:01 AM (EDT) on Saturday, June 2,
2012, and in the Annual Meeting Proceedings online
supplement to the June 20, 2012, issue of Journal of
Clinical Oncology. Onsite at the Meeting, this abstract will
be printed in the Saturday edition of ASCO Daily News.
LBA4003 Oral Abstract Session, Sat, 3:00 PM-6:00 PM
Phase III randomized trial of definitive chemoradiotherapy (CRT) with
FOLFOX or cisplatin and fluorouracil in esophageal cancer (EC): Final
results of the PRODIGE 5/ACCORD 17 trial. Presenting Author: Thierry
Conroy, Centre Alexis Vautrin, Vandoeuvre-lès-Nancy, France
The full, final text of this abstract will be available at
abstract.asco.org at 12:01 AM (EDT) on Saturday, June 2,
2012, and in the Annual Meeting Proceedings online
supplement to the June 20, 2012, issue of Journal of
Clinical Oncology. Onsite at the Meeting, this abstract will
be printed in the Saturday edition of ASCO Daily News.
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