CC BY-NC-ND 4.0 · Indian J Med Paediatr Oncol 2022; 43(02): 153-158
DOI: 10.1055/s-0042-1742445
Original Article

A Prospective Study to Evaluate the Efficacy of the Fluorouracil, Leucovorin, Oxaliplatin, and Docetaxel Chemotherapy Regimen in Patients with Locally Advanced and Metastatic Adenocarcinoma of Stomach

Vijay Kumar Srinivasalu
1   Department of Medical Oncology, Mazumdar Shaw Medical Center, Bangalore, Karnataka, India
,
Arun Philip
2   Department of Medical Oncology, Amrita Institute of Medical Sciences, Kochi, Kerala, India
,
Ranjini Pillai
2   Department of Medical Oncology, Amrita Institute of Medical Sciences, Kochi, Kerala, India
,
Wesley M. Jose
2   Department of Medical Oncology, Amrita Institute of Medical Sciences, Kochi, Kerala, India
,
Pavithran Keechilat
2   Department of Medical Oncology, Amrita Institute of Medical Sciences, Kochi, Kerala, India
› Author Affiliations

Abstract

Introduction In India, patients with gastric cancer present at an advanced stage, and there is no standard chemotherapy regimen. Al-Batran's fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) chemotherapy gave us a glimmer of hope.

Objectives Hence, we intended to evaluate the efficacy of FLOT chemotherapy in locally advanced and metastatic adenocarcinoma of stomach.

Materials and Methods In this single-center, prospective cohort, patients with locally advanced and metastatic gastric adenocarcinoma who required chemotherapy between March 2016 and November 2017 were included in the study. All patients received standard FLOT chemotherapy. The primary objective was to evaluate the safety and efficacy of FLOT chemotherapy in the Indian population. Overall survival (OS) and progression-free survival (PFS) were calculated through the plotted Kaplan–Meier curves.

Results In our study, 28 patients received FLOT chemotherapy. Their mean age was 55 years (range, 28–70 years) with a male preponderance (89.3%). Twenty-five patients had metastatic disease (89.3%), and three had locally advanced disease (10.7%). The median number of cycles was 4.5 (range, 1–8), and 75% received at least four cycles (n = 21). The hematological toxicities exhibited were neutropenia (50%) and febrile neutropenia (35.7%). Sixteen (57.1%) patients needed dose modifications due to treatment-related adverse effects (AEs). AEs led to treatment discontinuation in seven (25%) patients after the first cycle. The overall response rate in the intent-to-treat population was 52.7%, with the best-obtained response being a partial response, median PFS of 5 months, and median OS of 13 months.

Conclusion FLOT chemotherapy regimens induced excellent responses but with significantly increased toxicity, needing dose modifications, and hence, should be considered only in a young and fit patient.

Financial Support and Sponsorship

None.




Publication History

Article published online:
08 March 2022

© 2022. Indian Society of Medical and Paediatric Oncology. This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)

Thieme Medical and Scientific Publishers Pvt. Ltd.
A-12, 2nd Floor, Sector 2, Noida-201301 UP, India

 
  • References

  • 1 Rao DN, Ganesh B. Estimate of cancer incidence in India in 1991. Indian J Cancer 1998; 35 (01) 10-18
  • 2 Alberts SR, Cervantes A, van de Velde CJ. Gastric cancer: epidemiology, pathology and treatment. Ann Oncol 2003; 14 (Suppl. 02) ii31-ii36
  • 3 Pavithran K, Doval DC, Pandey KK. Gastric cancer in India. Gastric Cancer 2002; 5 (04) 240-243
  • 4 Yeole BB. Trends in cancer incidence in esophagus, stomach, colon, rectum and liver in males in India. Asian Pac J Cancer Prev 2008; 9 (01) 97-100
  • 5 Satyanarayana L, Asthana S. Life time risk for development of ten major cancers in India and its trends over the years 1982 to 2000. Indian J Med Sci 2008; 62 (02) 35-44
  • 6 Rastogi T, Devesa S, Mangtani P. et al. Cancer incidence rates among South Asians in four geographic regions: India, Singapore, UK and US. Int J Epidemiol 2008; 37 (01) 147-160
  • 7 Ajani JA. Evolving chemotherapy for advanced gastric cancer. Oncologist 2005; 10 (Suppl. 03) 49-58
  • 8 Foukakis T, Lundell L, Gubanski M, Lind PA. Advances in the treatment of patients with gastric adenocarcinoma. Acta Oncol 2007; 46 (03) 277-285
  • 9 Van Cutsem E, Moiseyenko VM, Tjulandin S. et al; V325 Study Group. Phase III study of docetaxel and cisplatin plus fluorouracil compared with cisplatin and fluorouracil as first-line therapy for advanced gastric cancer: a report of the V325 Study Group. J Clin Oncol 2006; 24 (31) 4991-4997
  • 10 Ajani JA, Moiseyenko VM, Tjulandin S. et al; V-325 Study Group. Quality of life with docetaxel plus cisplatin and fluorouracil compared with cisplatin and fluorouracil from a phase III trial for advanced gastric or gastroesophageal adenocarcinoma: the V-325 Study Group. J Clin Oncol 2007; 25 (22) 3210-3216
  • 11 Ajani JA, Moiseyenko VM, Tjulandin S. et al; V-325 Study Group. Clinical benefit with docetaxel plus fluorouracil and cisplatin compared with cisplatin and fluorouracil in a phase III trial of advanced gastric or gastroesophageal cancer adenocarcinoma: the V-325 Study Group. J Clin Oncol 2007; 25 (22) 3205-3209
  • 12 Shah MA, Janjigian YY, Stoller R. et al. Randomized multicenter phase ii study of modified docetaxel, cisplatin, and fluorouracil (DCF) Versus DCF Plus growth factor support in patients with metastatic gastric adenocarcinoma: A study of the US gastric cancer consortium. J Clin Oncol 2015; 33 (33) 3874-3879
  • 13 Hejna M, Raderer M, Zacherl J. et al. Phase II study of docetaxel in combination with oxaliplatin in patients with metastatic or locally advanced esophagogastric cancer previously untreated with chemotherapy for advanced disease: results of the Central European Cooperative Oncology Group Study ESGAS.1.2.001. Anticancer Drugs 2008; 19 (05) 535-539
  • 14 Kim JG, Sohn SK, Chae YS. et al. Multicenter phase II study of docetaxel plus oxaliplatin combination chemotherapy in patients with advanced gastric cancer: Daegu Gyeongbuk Oncology Group. Br J Cancer 2008; 98 (03) 542-546
  • 15 Park Y, Kim K, Choi M. et al. A Phase I/II trial of docetaxel (D) and oxaliplatin (O) in patients with advanced gastric cancer (AGC). In: 2008 ASCO annual meeting proceedings (post-meeting edition). J Clin Oncol 2008; 26: 15S
  • 16 Richards D, McCollum D, Wilfong L. et al. Phase II trial of docetaxel and oxaliplatin in patients with advanced gastric cancer and/or adenocarcinoma of the gastroesophageal junction. Ann Oncol 2008; 19 (01) 104-108
  • 17 Al-Batran SE, Hartmann JT, Probst S. et al; Arbeitsgemeinschaft Internistische Onkologie. Phase III trial in metastatic gastroesophageal adenocarcinoma with fluorouracil, leucovorin plus either oxaliplatin or cisplatin: a study of the Arbeitsgemeinschaft Internistische Onkologie. J Clin Oncol 2008; 26 (09) 1435-1442
  • 18 Al-Batran SE, Atmaca A, Hegewisch-Becker S. et al. Phase II trial of biweekly infusional fluorouracil, folinic acid, and oxaliplatin in patients with advanced gastric cancer. J Clin Oncol 2004; 22 (04) 658-663
  • 19 Al-Batran SE, Kerber A, Atmaca A. et al. Mitomycin C, 5-fluorouracil, leucovorin, and oxaliplatin as a salvage therapy for patients with cisplatin-resistant advanced gastric cancer: a phase I dose escalation trial. Onkologie 2007; 30 (1-2): 29-34
  • 20 Al Batron S, Hartman J, Hofheinz R. et al. Biweekly fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) for patients with metastatic adenocarcinoma of the stomach or esophagogastric junction: A Phase II trial of the Arbeitsgemein schaft internistische Onkologie. Ann Oncol 2006; 19: 1882-1887
  • 21 Oken MM, Creech RH, Tormey DC. et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol 1982; 5 (06) 649-655
  • 22 Cutsem VE, Boni C, Tabernero J. et al. Randomized Phase II study (GATE study) of docetaxel plus oxaliplatin with or without fluorouracil or capecitabine in metastatic or locally recurrent gastric cancer. J Clin Oncol 2011; (Suppl): 4018
  • 23 Messager M, Lefevre JH, Pichot-Delahaye V, Souadka A, Piessen G, Mariette C. FREGAT working group - FRENCH. The impact of perioperative chemotherapy on survival in patients with gastric signet ring cell adenocarcinoma: a multicenter comparative study. Ann Surg 2011; 254 (05) 684-693 , discussion 693