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

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LBA4000 Oral Abstract Session, Sat, 3:00 PM-6:00 PM<br />

A randomized, multicenter trial <strong>of</strong> epirubicin, oxaliplatin, and capecitabine<br />

(EOC) plus panitumumab in advanced esophagogastric cancer (REAL3).<br />

Presenting Author: Tom Samuel Waddell, Royal Marsden Hospital NHS<br />

Foundation Trust, London, United Kingdom<br />

The full, final text <strong>of</strong> this abstract will be available at<br />

abstract.asco.org at 12:01 AM (EDT) on Saturday, June 2,<br />

2012, and in the <strong>Annual</strong> <strong>Meeting</strong> <strong>Proceedings</strong> online<br />

supplement to the June 20, 2012, issue <strong>of</strong> Journal <strong>of</strong><br />

<strong>Clinical</strong> Oncology. Onsite at the <strong>Meeting</strong>, this abstract will<br />

be printed in the Saturday edition <strong>of</strong> ASCO Daily News.<br />

4002 Oral Abstract Session, Sat, 3:00 PM-6:00 PM<br />

Randomized phase III study <strong>of</strong> irinotecan (CPT-11) versus weekly paclitaxel<br />

(wPTX) for advanced gastric cancer (AGC) refractory to combination<br />

chemotherapy (CT) <strong>of</strong> fluoropyrimidine plus platinum (FP): WJOG4007<br />

trial. Presenting Author: Shinya Ueda, Kinki University School <strong>of</strong> Medicine,<br />

Osakasayama, Japan<br />

Background: A combination CT <strong>of</strong> FP has been regarded as the standard<br />

first-line treatment for AGC. Although two randomized trials showed a<br />

survival benefit <strong>of</strong> second-line CT (CPT-11 or docetaxel) compared with<br />

best supportive care, no standard regimen has been established. In Japan,<br />

wPTX has been used more frequently than docetaxel as the second-line CT.<br />

The objective <strong>of</strong> this study was to compare CPT-11 with wPTX in patients<br />

(pts) with AGC refractory to FP. Methods: Patients with AGC refractory to the<br />

first-line FP regimen were randomized 1:1 to either CPT-11 (150 mg/m2 ,<br />

q2w) or wPTX (80 mg/m2 , days 1, 8, 15, q4w). The primary endpoint was<br />

overall survival (OS) and secondary endpoints were progression-free survival<br />

(PFS), overall response rate (ORR), adverse events and receiving rates<br />

<strong>of</strong> third-line CT. To demonstrate an increase in median OS from 5 months<br />

(wPTX) to 7.5 months (CPT-11) with 2-sided alpha 5% and 80% power,<br />

220 pts were required. Results: Between Aug 2007 and Aug 2010, 223 pts<br />

were enrolled; 112 pts were randomized to CPT-11 and 111 pts to wPTX.<br />

Baseline characteristics were well balanced between arms. Median OS was<br />

8.4 months for CPT-11 and 9.5 months for wPTX (HR 1.132; 95% CI,<br />

0.86-1.49; p�0.38). Median PFS was 2.3 months for CPT-11 and 3.6<br />

months for wPTX (HR 1.14; 95% CI, 0.88-1.49; p�0.33). The ORR was<br />

13.6% (12/88) for CPT-11 and 20.9% (19/91) for wPTX (p�0.20). The<br />

most common grade 3/4 adverse events were neutropenia (39.1% for<br />

CPT-11 vs. 28.7% for wPTX), anemia (30.0% vs. 21.3%), anorexia<br />

(17.3% vs. 7.4%) and fatigue (12.7% vs. 6.5%). Four (4%) CPT-11 and<br />

three (3%) wPTX recipients died within 30 days after the last administration.<br />

Subsequent CT was performed in 80 pts (71%) for CPT-11 and 97 pts<br />

(89%) for wPTX. Seventy-five pts (67%) in the CPT-11 group and 87 pts<br />

(80%) in the wPTX group received the crossover CT. Conclusions: The<br />

WJOG4007 trial, the first phase III study comparing second-line CT<br />

regimens for AGC, did not demonstrate the superiority <strong>of</strong> CPT-11 over<br />

wPTX. Thus, wPTX can be adopted as a control arm <strong>of</strong> future phase III trials<br />

<strong>of</strong> second-line CT for AGC.<br />

Gastrointestinal (Noncolorectal) Cancer<br />

239s<br />

LBA4001 Oral Abstract Session, Sat, 3:00 PM-6:00 PM<br />

Intergroup Trial <strong>of</strong> Adjuvant Chemotherapy in Adenocarcinoma <strong>of</strong> the<br />

Stomach (ITACA-S) trial: Comparison <strong>of</strong> a sequential treatment with<br />

irinotecan (CPT-11) plus 5-fluorouracil (5-FU)/folinic acid (LV) followed by<br />

docetaxel and cisplatin versus a 5-FU/LV regimen as postoperative treatment<br />

for radically resected gastric cancer. Presenting Author: Emilio<br />

Bajetta, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy<br />

The full, final text <strong>of</strong> this abstract will be available at<br />

abstract.asco.org at 12:01 AM (EDT) on Saturday, June 2,<br />

2012, and in the <strong>Annual</strong> <strong>Meeting</strong> <strong>Proceedings</strong> online<br />

supplement to the June 20, 2012, issue <strong>of</strong> Journal <strong>of</strong><br />

<strong>Clinical</strong> Oncology. Onsite at the <strong>Meeting</strong>, this abstract will<br />

be printed in the Saturday edition <strong>of</strong> ASCO Daily News.<br />

LBA4003 Oral Abstract Session, Sat, 3:00 PM-6:00 PM<br />

Phase III randomized trial <strong>of</strong> definitive chemoradiotherapy (CRT) with<br />

FOLFOX or cisplatin and fluorouracil in esophageal cancer (EC): Final<br />

results <strong>of</strong> the PRODIGE 5/ACCORD 17 trial. Presenting Author: Thierry<br />

Conroy, Centre Alexis Vautrin, Vandoeuvre-lès-Nancy, France<br />

The full, final text <strong>of</strong> this abstract will be available at<br />

abstract.asco.org at 12:01 AM (EDT) on Saturday, June 2,<br />

2012, and in the <strong>Annual</strong> <strong>Meeting</strong> <strong>Proceedings</strong> online<br />

supplement to the June 20, 2012, issue <strong>of</strong> Journal <strong>of</strong><br />

<strong>Clinical</strong> Oncology. Onsite at the <strong>Meeting</strong>, this abstract will<br />

be printed in the Saturday edition <strong>of</strong> ASCO Daily News.<br />

Visit abstract.asco.org and search by abstract for the full list <strong>of</strong> abstract authors and their disclosure information.

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