Random assignment multicenter phase II study of modified docetaxel, cisplatin, fluorouracil (mDCF) versus DCF with growth factor support (GCSF) in metastatic gastroesophageal adenocarcinoma (GE).

Shah, M. A.; Shibata, Shigeru; Stoller, Ronald G.; Kemeny, Margaret; Ritch, Paul S.; Krishnamurthi, Smitha; Su, Y-Y.; Janjigian, Y. Y.; Capanu, M.; Kelsen, David P.

doi:10.1200/jco.2010.28.15_suppl.4014

Cited by 36 publications

(39 citation statements)

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“…As did Tomasello et al, Shah et al also reported the de Gramont-based DCF regimen in 41 patients with AGC [35]. In that study, patients were randomly assigned to Arm A: de Gramont-based DCF (docetaxel 40 mg/m 2 , 5-FU 400 mg/m 2 , LV 400 mg/m 2 , 5-FU 1,000 mg/m 2 /day on days 1 and 2, cisplatin 40 mg/m 2 on day 3, every 2 weeks), or Arm B: standard DCF [35].…”

Section: Discussionmentioning

confidence: 92%

“…In that study, patients were randomly assigned to Arm A: de Gramont-based DCF (docetaxel 40 mg/m 2 , 5-FU 400 mg/m 2 , LV 400 mg/m 2 , 5-FU 1,000 mg/m 2 /day on days 1 and 2, cisplatin 40 mg/m 2 on day 3, every 2 weeks), or Arm B: standard DCF [35]. The response rate of Arm A versus Arm B was 52 versus 34 %, respectively.…”

Section: Discussionmentioning

confidence: 99%

“…The administration of the de Gramont regimen in combination with docetaxel and cisplatin has been previously reported by Tomasello et al and Shah et al [34,35], but with only one 5-FU bolus, and a 46-h infusion of 5-FU in combination with cisplatin and docetaxel has not been previously reported. This study was planned to analyze the efficacy, toxicity, and convenience of a de Gramont-based DCF regimen as a first-line treatment in a larger number of patients with AGC.…”

Section: Introductionmentioning

confidence: 99%

“…The de Gramont regimen has also been investigated for the treatment of AGC either alone [28], in combination with cisplatin [29,30], in combination with irinotecan [30,31], in combination with cisplatin plus mitomycin-C [32], in combination with cisplatin plus epirubicin [33], or in combination with docetaxel plus cisplatin [34,35]. The results of these trials were encouraging in terms of both the safety profile and the activity.…”

Section: Introductionmentioning

confidence: 99%

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Bimonthly regimen of high-dose leucovorin, infusional 5-fluorouracil, docetaxel, and cisplatin (modified DCF) in advanced gastric adenocarcinoma

et al. 2012

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Background The combination of docetaxel, cisplatin, and 5-fluorouracil (DCF) is an effective but highly toxic regimen for the treatment of advanced gastric cancer. To improve tolerability while maintaining the efficacy of the DCF regimen, we developed a modified DCF regimen including an infusional 5-fluorouracil administration according to the de Gramont regimen. Methods In this study, 70 patients with advanced gastric cancer were treated. Each 2-week cycle consisted of docetaxel (60 mg/m 2 ), cisplatin (50 mg/m 2 ), a 5-fluorouracil (400 mg/m 2 ) IV bolus, and 5-fluorouracil (2,400 mg/m 2 ) IV over 46 h plus leucovorin (400 mg/m 2 ) IV over 2 h. Results The median progression-free survival and overall survival were 9.0 months (95 % CI, 7.1-10.9) and 10.8 months (95 % CI, 7.4-14.2), respectively; the 1-year and 2-year overall survival rates were 46.3 and 18.4 %, respectively. Twenty-nine (41.4 %) partial responses, 19 (27.1 %) stable disease, and 22 (31.4 %) progression of disease were observed. Grade 3-4 toxicities included neutropenia (37.1 %), febrile neutropenia (15.7 %), thrombocytopenia (10.0 %), anemia (8.6 %), nausea and vomiting (10.0 %), stomatitis (5.7 %), infection (8.6 %), and diarrhea (2.9 %). ConclusionsOur results show that a de Gramont-based DCF regimen may have tolerable toxicities and be an effective and convenient palliative treatment for advanced gastric cancer.

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Section: Discussionmentioning

confidence: 92%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Bimonthly regimen of high-dose leucovorin, infusional 5-fluorouracil, docetaxel, and cisplatin (modified DCF) in advanced gastric adenocarcinoma

et al. 2012

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“…However, split-dose cisplatin has been most often studied for its potential to reduce severe toxicities in toxic regimens such as the DCF regimen (docetaxel plus cisplatin plus fluorouracil) [1] and the irinotecan plus cisplatin regimen [3]. Randomized and nonrandomized phase II studies have demonstrated that these regimens hold some promise in treatment of metastatic gastroesophageal/gastric cancer [18,19]. However, the survival benefit of these modified regimens remains unclear, despite their ability to alleviate toxicities and improve treatment compliance.…”

Section: Discussionmentioning

confidence: 99%

A randomized phase II study comparing S-1 plus weekly split-dose cisplatin with S-1 plus standard-dose cisplatin as first-line chemotherapy for advanced gastric cancer

et al. 2013

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Background S-1 plus weekly split-dose cisplatin demonstrated promising results in previous phase I and II studies for advanced gastric cancer (AGC) patients. Methods In this randomized phase II study, the efficacy and safety of S-1 plus weekly split-dose cisplatin (SWP, S-1 daily oral dose of 80-120 mg according to body surface area on days 1-14, and cisplatin 20 mg/m 2 i.v. on days 1 and 8 every 3 weeks) were compared with those of S-1 plus standard-dose cisplatin (SP) as first-line chemotherapy for AGC patients. The primary endpoint was 1-year survival rate.Results Patients were randomized into two groups: 18 in the SWP arm and 19 in the SP arm. This trial was terminated early because of low patient enrollment. The 1-year survival rate was 61 % [95 % confidence interval (CI), 36-86 %] and 53 % (95 % CI, 30-75 %) in the SWP and SP arms, respectively. However, the median survival time was 12.3 months (9.9-14.6 months) and 15.7 months (4.0-27.4 months), respectively (P = 0.064). Progressionfree survival was significantly shorter in the SWP arm than in the SP arm (P = 0.047). Toxicity tended to be milder in the SWP arm than in the SP arm. For approximately 40 % of patients in the SWP arm, cisplatin was omitted on day 8 and treatment delayed because of prolonged myelosuppression. Conclusions No clear benefits of adding cisplatin to S-1 in the SWP arm were demonstrated in this study. At this point, split-dose cisplatin combined with S-1 cannot be recommended for use in clinical practice.

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Phase II study of first-line biweekly docetaxel and cisplatin combination chemotherapy in advanced gastric cancer

Quintero-Aldana

Jorge

Grande

et al. 2015

Cancer Chemother Pharmacol

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Random assignment multicenter phase II study of modified docetaxel, cisplatin, fluorouracil (mDCF) versus DCF with growth factor support (GCSF) in metastatic gastroesophageal adenocarcinoma (GE).

Cited by 36 publications

References 0 publications

Bimonthly regimen of high-dose leucovorin, infusional 5-fluorouracil, docetaxel, and cisplatin (modified DCF) in advanced gastric adenocarcinoma

Bimonthly regimen of high-dose leucovorin, infusional 5-fluorouracil, docetaxel, and cisplatin (modified DCF) in advanced gastric adenocarcinoma

A randomized phase II study comparing S-1 plus weekly split-dose cisplatin with S-1 plus standard-dose cisplatin as first-line chemotherapy for advanced gastric cancer

Phase II study of first-line biweekly docetaxel and cisplatin combination chemotherapy in advanced gastric cancer

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