In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 30, No. 15_suppl ( 2012-05-20), p. 4061-4061
Abstract:
4061 Background: Preop chemo and radiotherapy (RT) with weekly irinotecan (I), cisplatin (C) and 5040 cGy is tolerable and active [Cancer, in press]. Bevacizumab (B) + weekly I/C in advanced esophagogastric cancer increased response rate and PFS without an increase in toxicity [JCO 24: 5201; 2006] . In a phase II trial in esophageal adenocarcinoma (EA) we combed B + I/C with RT as preop therapy. A toxicity analysis after 10 patients (pts) undergoing surgery indicated no unexpected toxicity with B [JCO 27: Abstract 4573; 2009], and we completed a planned accrual of 33 pts. Methods: Pts had resectable distal esophageal or Siewert’s I or II EA, T2-3 or N1 staged by EUS, PET, and CT scan. Induction chemo: I: 50-65 mg/m 2 + C: 30 mg/m 2 weeks 1,2,4,5, B: 7.5 mg/kg weeks 1 and 4; Chemort: 180 cGy daily fractions to 5040 cGy, I/C weeks 7,8,10,11+ B weeks 7,10. Esophagectomy was planned 6-8 weeks after RT. Postop: B: 7.5 mg/kg every 3 weeks for 8 cycles. Results: 33 pts were enrolled. 26 male: 7 female; distal esophagus 11 (33%), GEJ 22 (67%); 21 T3N1 (64%); 10 T3N0 (30%); 2 T2N0-1 (6%). 25/33 pts went to surgery (76%), 24 had R0 resection (73%). Pathologic CR 5 pts (15%). 8 pts did not going to surgery: 2 for adverse events (9%, 1 CVA due to patent foramen ovale, 1 esophageal perforation due to endoscopic biopsy), 6 for progressive disease (18%). 21/24 pts (88%) received adjuvant B, 20 (95%) completed all cycles. Grade 3/4 toxicity in 30 evaluable pts during chemort: 24% neutropenia, 3% neutropenic fever, 23% esophagitis, 13% dehydration, 13% thrombocytopenia, 7% pulmonary embolism, 3% nausea/vomiting. Surgical complications: 3 anastomotic leaks (12%), 4 respiratory failure (16%), 1 pulmonary embolism (4%), 2 post op deaths (8%). At a median follow up of 20 months, PFS was 14 months and OS was 30 months. Conclusions: The addition of B to preop chemoRT in EA was tolerable without increase in treatment toxicity or surgical complications. There was no suggestion of improved pathologic CR, PFS, or OS with the addition of B to I/C/RT. Evaluation of B in phase III trials of chemort does not appear warranted. Supported by a grant from Genentech.
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/jco.2012.30.15_suppl.4061
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2012
detail.hit.zdb_id:
2005181-5
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