A multi‐institutional phase 2 study of neoadjuvant gemcitabine and oxaliplatin with radiation therapy in patients with pancreatic cancer. Issue 15 (29th May 2013)

• Record Type: Journal Article
• Authors: Kim, Edward J.; Ben‐Josef, Edgar; Herman, Joseph M.; Bekaii‐Saab, Tanios; Dawson, Laura A.; Griffith, Kent A.; Francis, Isaac R.; Greenson, Joel K.; Simeone, Diane M.; Lawrence, Theodore S.; Laheru, Daniel; Wolfgang, Christopher L.; Williams, Terence; Bloomston, Mark; Moore, Malcolm J.; Wei, Alice; Zalupski, Mark M.
• Is Part Of: Cancer. Volume 119:Issue 15(2013)
• Page Start: 2692
• Page End: 2700
• Publication Date: 2013-05-29
• Subjects: Cancer -- Periodicals; Cancer -- Cytopathology -- Periodicals; 616.99405
• DOI: 10.1002/cncr.28117
• Languages: English
• ISSNs: 0008-543X

Abstract

<abstract abstract-type="main"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="cncr28117-sec-0001" sec-type="section"> <title>BACKGROUND</title> <p>The purpose of this study was to evaluate preoperative treatment with full‐dose gemcitabine, oxaliplatin, and radiation therapy (RT) in patients with localized pancreatic cancer.</p> </sec> <sec id="cncr28117-sec-0002" sec-type="section"> <title>METHODS</title> <p>Eligibility included confirmation of adenocarcinoma, resectable or borderline resectable disease, a performance status ≤2, and adequate organ function. Treatment consisted of two 28‐day cycles of gemcitabine (1 g/m<sup>2</sup> over 30 minutes on days 1, 8, and 15) and oxaliplatin (85 mg/m<sup>2</sup> on days 1 and 15) with RT during cycle 1 (30 Gray [Gy] in 2‐Gy fractions). Patients were evaluated for surgery after cycle 2. Patients who underwent resection received 2 cycles of adjuvant chemotherapy.</p> </sec> <sec id="cncr28117-sec-0003" sec-type="section"> <title>RESULTS</title> <p>Sixty‐eight evaluable patients received treatment at 4 centers. By central radiology review, 23 patients had resectable disease, 39 patients had borderline resectable disease, and 6 patients had unresectable disease. Sixty‐six patients (97%) completed cycle 1 with RT, and 61 patients (90%) completed cycle 2. Grade ≥3 adverse events during preoperative therapy included neutropenia (32%), thrombocytopenia (25%), and biliary obstruction/cholangitis (14%). Forty‐three patients underwent resection (63%), and complete (R0) resection was achieved in 36 of those 43 patients (84%). The median overall survival was 18.2 months (95% confidence interval, 13–26.9 months) for all patients, 27.1 months (95% confidence interval, 21.2–47.1 months) for those who underwent resection, and 10.9 months (95% confidence interval, 6.1–12.6 months) for those who did not undergo resection. A decrease in CA 19‐9 level after neoadjuvant therapy was associated with R0 resection (<italic>P</italic> = .02), which resulted in a median survival of 34.6 months (95% confidence interval, 20.3–47.1 months). Fourteen patients (21%) are alive and disease free at a median follow‐up of 31.4 months (range, 24–47.6 months).</p> </sec> <sec id="cncr28117-sec-0004" sec-type="section"> <title>CONCLUSIONS</title> <p>Preoperative therapy with full‐dose gemcitabine, oxaliplatin, and RT was feasible and resulted in a high percentage of R0 resections. The current results are particularly encouraging, because the majority of patients had borderline resectable disease. <bold><italic>Cancer</italic> 2013</bold>;119:2692–2700. © <italic>2013 American Cancer Society</italic>.</p> </sec> </abstract>