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- Title
A phase II trial of modified FOLFOX6 as first-line therapy for adenocarcinoma of an unknown primary site.
- Authors
Shin, Dong-Yeop; Choi, Yoon; Lee, Hyo-Rak; Na, Im; Yuh, Young; Kim, Bong-Seog; Chung, Ik; Bae, Woo-Kyun; Shim, Hyun-Jeong; Song, Eun-Kee; Yang, Sung; Kang, Hye; Choi, Yoon Hee; Na, Im Il; Yuh, Young Jin; Chung, Ik Joo; Yang, Sung Hyun; Kang, Hye Jin
- Abstract
<bold>Purpose: </bold>The aim of the study was to assess the clinical activity and toxicity of oxaliplatin and leucovorin in combination with bolus and continuous infusional 5-fluorouracil administered every 2 weeks (modified FOLFOX-6 regimen) to patients with adenocarcinoma of an unknown primary site (ACUP).<bold>Methods: </bold>Previously untreated ACUP patients were treated with oxaliplatin (100 mg/m(2)) and leucovorin (200 mg/m(2)) as a 2-h infusion followed by bolus administration of 5-fluorouracil (400 mg/m(2)) and continuous infusion of 5-fluorouracil (2400 mg/m(2)) every 2 weeks.<bold>Results: </bold>A total of 23 patients were enrolled and treated with a modified FOLFOX-6 regimen between May 2009 and November 2014. This trial was terminated before the scheduled enrollment due to poor accrual. A total of 134 cycles of mFOLFOX-6 were administered to 23 patients. The median number of cycles of mFOLFOX-6 was 5 (range 1-12). Among 20 patients whose tumor responses were evaluable, seven patients showed a partial response (no complete response), with an objective response rate of 35.0%. The median duration of response was 3.9 months (range 3.0-19.8). The median progression-free survival and overall survival were 3.0 and 9.5 months, respectively (95% confidence interval 1.4-6.7 months and 4.8-26.4 months, respectively). Treatment-related toxicity was manageable.<bold>Conclusions: </bold>mFOLFOX-6 showed modest activity in treatment-naïve patients with ACUP. A future, prospective large-scale study incorporating a parallel molecular prediction marker study is warranted.
- Subjects
CLINICAL trials; OXALIPLATIN; FOLINIC acid; TOXICITY testing; DRUG administration; THERAPEUTICS; ADENOCARCINOMA; ANTINEOPLASTIC agents; COMPARATIVE studies; FLUOROURACIL; RESEARCH methodology; MEDICAL cooperation; PROGNOSIS; ORGANOPLATINUM compounds; RESEARCH; SURVIVAL; EVALUATION research; CANCER of unknown primary origin; TREATMENT effectiveness
- Publication
Cancer Chemotherapy & Pharmacology, 2016, Vol 77, Issue 1, p163
- ISSN
0344-5704
- Publication type
journal article
- DOI
10.1007/s00280-015-2904-7