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Modified FOLFOX-6 as 1st line therapy for adenocarcinoma of unknown primary: a multicenter phase II study

Date

19 Dec 2015

Session

Poster presentation 1

Presenters

Dong-Yeop Shin

Citation

Annals of Oncology (2015) 26 (suppl_9): 42-70. 10.1093/annonc/mdv523

Authors

D. Shin1, H. Lee2, I.I. Na2, Y.J. Yuh3, B.S. Kim4, I.J. Chung5, W. Bae5, H. Shim5, E. Song6, S.H. Yang2, H.J. Kang2

Author affiliations

  • 1 Internal Medicine, Korea Institute of Radiological & Medical Sciences, 139-706 - Seoul/KR
  • 2 Internal Medicine, Korea Institute of Radiological & Medical Sciences, Seoul/KR
  • 3 Internal Medicine, Sanggye Paik Hospital, Seoul/KR
  • 4 Internal Medicine, Veterance Hospital, Seoul, Seoul/KR
  • 5 Internal Medicine, Chonnam National University Hwasun Hospital, Hwasun-Gun/KR
  • 6 Internal Medicine, Chonbuk National University Medical School, Jeon Ju/KR
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Aim/Background

The aim of the study was to assess the clinical activity and toxicity of oxaliplatin and leucovorin in combination with bolus and continuous infusion of 5-fluorouracil treated every 2 weeks (modified FOLFOX-6 regimen) in patients with adenocardinoma of unknown primary (ACUP).

Methods

Previously untreated ACUP patients were enrolled and treated with oxaliplatin 100mg/m2 and leucovorin 200mg/m2 simultaneously as 2-hour infusion followed by bolus administration of 5-fluorouracil 400mg/m2 and continuous infusion of 5-fluorouracil 2400mg/m2 every 2 weeks. Response evaluation was performed every 3 cycles according to the response assessment in solid tumours version 1.1, and toxicities were assessed using the National Cancer Institute Common Toxicity Criteria for adverse events version 3.0 every 2 weeks.

Results

Data from 23 patients who had been enrolled in this multicenter phase II trial between May 2009 and Nov 2014 was collected for an interim analysis. A total of 134 cycles of modified FOLFOX-6 were treated in these 23 patients. The median number of cycles of modified FOLFOX-6 was 5 (range, 1–12). Among 20 patients whose tumor responses were evaluable, 7 patients showed partial response (no complete response), which objective response rate was 35.0% (95% confidence interval: 13.2 - 52.9). The median duration of response was 3.9 months (range, 3.0–19.8). Median progression-free survival was 3.0 months (95% CI: 1.8–6.7 months) in whole patients, which was 2.4 months for non-responders and 5.8 months for responders, respectively. Adverse events of all grade occurred in 22 patients (95.7%), and a grade ≥ 3 event occurred in 7 patients (30.4%). Grade ≥ 3 hematologic toxicities occurred in 4 patients (17.4%), and grade ≥ 3 non-hematologic toxicities occurred in 6 patients (26.1%), respectively. Most common hematologic toxicities were anemia and neutropenia (78.3% and 65.2%, respectively), while nausea was most frequent non-hematologic toxicity (47.8%).

Conclusions

Modified FOLFOX-6 showed modest activity in treatment-naïve patients with ACUP. Future prospective large scale study incorporating parallel molecular prediction marker study is warranted.

Clinical trial identification

WHO-ICTRP ID: KCT0000410

Disclosure

All authors have declared no conflicts of interest.

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