Journal of Clinical Oncology, 2007 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 25, No 18S (June 20 Supplement), 2007: 4533
© 2007 American Society of Clinical Oncology

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Abstract

E1201: An Eastern Cooperative Oncology Group (ECOG) randomized phase II trial of neoadjuvant preoperative paclitaxel/cisplatin/RT or irinotecan/cisplatin/RT in endoscopy with ultrasound (EUS) staged adenocarcinoma of the esophagus

Johns Hopkins Onc Ctr, Baltimore, MD; Dana-Farber Cancer Institute, Boston, MA; Montefiore Hospital, Bronx, NY; Thomas Jefferson University, Philadelphia, PA; Northwestern University, Chicago, IL

4533

Background: E1201 included operable esophageal adenocarcinoma, staged II-IVa by EUS. Endpoints were pathologic complete response (pCR), toxicity, and tolerability of these two experimental regimens. pCR was used as a surrogate endpoint. As previously reported, the pCr rates indicated that these regimens did not meet criteria for further study based on a target of 45% against the null hypothesis of 25% for standard therapy. This report contains details of toxicity, tolerability of adjuvant chemotherapy, and prognostic value of EUS staging. Materials/Methods: 90 eligible pts enrolled. Arm A was Cisplatin (C) 30mg/m² and Irinotecan (I) 50 mg/m² on days (d) 1,8,22,29 of 45 Gy RT/5 weeks. Post-op therapy was C 30 mg/m² and I 65 mg/m² d 1, 8 q21 days x 3. Arm B therapy was C 30 mg/m² and Paclitaxel (P) 50 mg/m² 1 hour infusion d 1,8,15, 22, 29 with RT. Postoperative therapy was C 75 mg/m² and P 175 mg/m² day 1 q21 days x 3. Results: Of all eligible patients, 83% (38/46) and 70% (31/44) had a complete resection with negative margins and 6/46 (15%) (95% CI = 5%, 26%) and 7/44 (16%) (95% CI = 7%, 30%) had pCR on arm A and B respectively. Confirmed EUS staging was available for 71 pts, Path CR rate was 3/19(16%) for stage T_{2- 3}N₀M₀ and 7/52(14%) for stages T_1–3N₁M₀ or T_1–3N_{0- 1}M_1a. The incidence of grade 3 hematology toxicity, dysphagia, and diarrhea during neoadjuvant therapy were 20 (43%), 6 (13%), 4 (9%) for arm A (n_TOX=47) and 18 (39%), 9 (20%), and 1 (23%) for arm B (n_TOX=46). Zero, one, two and three cycles of adjuvant chemotherapy were received by 26%, 20 %, 5% and 49% of operated patients in arm A (n=41) and 36%, 14%, 3%, and 47% in arm B (n=36). Two of 77 (3%) operated patients died within 30 days of surgery. Conclusions: The low pCR rates suggest that neither regimen is likely to advance treatment of esophageal/GEJ adenoca over preoperative cisplatin/5-FU/RT and therefore do not warrent pursuing. EUS stage did not appear to influence response rate with these regimens. Moreover, these regimens are associated with significant toxicity and, as with other regimens, only a minority of patients were able to receive the planned adjuvant therapy. Survival follow-up continues.

No significant financial relationships to disclose.

Abstract presentation from the 2007 ASCO Annual Meeting