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A Phase I/II Study of Docetaxel, Oxaliplatin, and Fluorouracil (D-FOX) Chemotherapy in Patients With Untreated Locally Unresectable or Metastatic Adenocarcinoma of the Stomach and Gastroesophageal Junction

Blum Murphy, Mariela, A., MD*; Qiao, Wei, MS; Mewada, Nishith, MD*; Wadhwa, Roopma, MD, MHA*; Elimova, Elena, MD, MSc*; Takashi, Taketa, MD*; Ho, Linus, MD, PhD*; Phan, Alexandria, MD; Baker, Jackie, RN, MSN, Ed*; Ajani, Jaffer, MD*

American Journal of Clinical Oncology: April 2018 - Volume 41 - Issue 4 - p 321–325
doi: 10.1097/COC.0000000000000271
Original Articles: Gastrointestinal

Background: A randomized phase III study established docetaxel, cisplatin, and 5-fluorouracil (DCF) as one of the standard treatments for patients with untreated advanced gastric cancer (AGC). However, DCF use is limited due toxicity. With the purpose to evaluate a less toxic regimen, we conducted a single arm, phase I/II trial of modified DCF (oxaliplatin, 5-fluorouracil, and docetaxel [D-FOX]) for untreated AGC patients. The primary objective of the phase I study was to determine the maximum tolerated dose of docetaxel and for the phase II study was to assess the progression-free survival (PFS) at 6 months and overall survival (OS).

Patients and Methods: We enrolled a total of 98 patients with AGC. Docetaxel and oxaliplatin were administered intravenously on day 1 and 5-fluorouracil was infused starting on day 1 over 48 hours. Cycles were repeated every 2 weeks and patients were monitored for toxicities. Kaplan-Meir curve was used to estimate unadjusted OS and PFS.

Results: The maximum tolerated dose of docetaxel was 50 mg/m2. In total, 24 (45%) patients experienced grade 2 adverse events, 22 (41%) experienced grade 3, and 1 (1.9%) experienced grade 4 toxicity. The median PFS in the phase II portion of the study was approximately 6.5 (95% confidence interval, 5.5-9.5) months and the median OS was 11.1 (95% confidence interval, 9.4-18.8) months.

Conclusions: D-FOX administered every 2 weeks is a well-tolerated and active regimen in untreated AGC patients.

Departments of *GI Medical Oncology

Biostatistics, The University of Texas, MD Anderson Cancer Center

Department of Hematology-Oncology, Houston-Methodist Hospital, Houston, TX

The authors declare no conflicts of interest.

Reprints: Mariela A. Blum Murphy, MD, Department of GI Medical Oncology, Unit 426, MD Anderson Cancer Center, 1400 Holcombe Blvd, Houston, TX 77030. E-mail: mblum1@mdanderson.org.

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