A randomized trial in patients with gemcitabine refractory pancreatic cancer. Final results of the CONKO 003 study

Pelzer, Uwe; Kubica, Krystian; Stieler, Jens; Schwaner, Ingo; Heil, Gerhard; Görner, Martin; Mölle, Matthias; Hilbig, A.; Dörken, Bernd; Riess, Hanno; Oettle, Helmut

doi:10.1200/jco.2008.26.15_suppl.4508

Cited by 101 publications

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“…In a preliminary report from the CONKO-003 trial, the use of second-line chemotherapy was compared with best supportive care (2). The study revealed the benefit of combination therapy with oxaliplatin, 5-FU and leucovorin as a second-line therapy compared with 5-FU and leucovorin (19). There have been other studies concerning combination chemotherapy for second-line therapy in pancreatic cancer with biological agents.…”

Section: Discussionmentioning

confidence: 99%

Phase II study of palliative S-1 in combination with cisplatin as second-line chemotherapy for gemcitabine-refractory pancreatic cancer patients

et al. 2012

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Abstract. In this study, we examined the efficacy and toxicity of S-1 with cisplatin as a second-line palliative chemotherapy for gemcitabine-refractory pancreatic cancer patients. Patients who had been previously treated with gemcitabine-based chemotherapy as palliative first-line chemotherapy received S-1/cisplatin [body surface area (BSA) <1.25 m 2 , S-1 40 mg/ day; BSA ≤1.25 to <1.5 m 2 , 50 mg/day; BSA ≥1.5 m 2 60 mg/ day, orally, bid, daily on days 1-14 followed by a 7-day washout and cisplatin 60 mg/m 2 /day intravenously on day 1] every three weeks. The enrollment of 32 patients was planned, but the study was terminated early, prior to the first stage, following the enrollment of 11 patients. The median age of the patients was 56 (range, 42-74) years. Nine patients had a performance status (PS) of one. In total, there were 21 chemotherapy cycles and the median treatment duration was 21 (range, 7-96) days. Of the 11 patients, five could not be evaluated due to discontinuation prior to the response evaluation. One of the six evaluable patients achieved stable disease (9.1% in intention to treat analysis and 16.7% in per-protocol analysis), while five had progressive disease. Grade 3-4 hematological toxicities were anemia in one, neutropenia in one and thrombocytopenia in one cycle. Grade 3-4 nonhematological toxicities were fatigue in three, nausea in four, anorexia in two, diarrhea in one and peripheral neuropathy in two cycles. With a median follow-up period of 8.9 (range, 3.2-11.3) months, the median time to progression was 44 days [95% confidence interval (CI) 25.4-62.6] and the median overall survival was 81 days (95% CI 9.3-152.7). Combination chemotherapy with S-1 and cisplatin as applied in this study did not result in promising antitumor activity, a high degree of toxicity and poor compliance.

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Section: Discussionmentioning

confidence: 99%

Phase II study of palliative S-1 in combination with cisplatin as second-line chemotherapy for gemcitabine-refractory pancreatic cancer patients

et al. 2012

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“…Recently, another oxaliplatinbased regimen, 5-FU/FA plus oxaliplatin (OFF), was shown to offer significantly improved survival compared with 5-FU/FA (FF) in a phase III trial (CONKO 003) (Pelzer et al, 2008). In this randomised trial, including 160 gemcitabine-pretreated patients with advanced pancreatic cancer, patients receiving OFF achieved a median PFS of 13 weeks (P ¼ 0.012) and a median OS of 26 weeks (P ¼ 0.014), compared with 9 and 13 weeks, respectively, for FF-treated patients.…”

Section: Discussionmentioning

confidence: 99%

“…Furthermore, an oxaliplatin and 5-FU combination, at various doses and schedules, has been evaluated as second-line chemotherapy in pancreatic cancer patients after gemcitabine failure (Tsavaris et al, 2005;Gebbia et al, 2007;Novarino et al, 2009). Recently, a German group has reported that the 5FU/folinic acid (FA) plus oxaliplatin (OFF) regimen could prolong survival and improve the quality of life of advanced pancreatic cancer patients after gemcitabine failure compared with best supportive care alone with or without 5FU/FA (FF) (Oettle et al, 2005;Pelzer et al, 2008).…”

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confidence: 99%

A randomised phase II study of modified FOLFIRI.3 vs modified FOLFOX as second-line therapy in patients with gemcitabine-refractory advanced pancreatic cancer

et al. 2009

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BACKGROUND: Only a few clinical trials have been conducted in patients with advanced pancreatic cancer after failure of first-line gemcitabine-based chemotherapy. Therefore, there is no current consensus on the treatment of these patients. We conducted a randomised phase II study of the modified FOLFIRI.3 (mFOLFIRI.3; a regimen combining 5-fluorouracil (5-FU), folinic acid, and irinotecan) and modified FOLFOX (mFOLFOX; a regimen combining folinic acid, 5-FU, and oxaliplatin) regimens as second-line treatments in patients with gemcitabine-refractory pancreatic cancer. METHODS: The primary end point was the 6-month overall survival rate. The mFOlFIRI.3 regimen consisted of irinotecan (70 mg m À2 ; days 1 and 3), leucovorin (400 mg m À2 ; day 1), and 5-FU (2000 mg m À2 ; days 1 and 2) every 2 weeks. The mFOLFOX regimen was composed of oxaliplatin (85 mg m À2 ; day 1), leucovorin (400 mg m À2 ; day 1), and 5-FU (2000 mg m À2 ; days 1 and 2) every 2 weeks. RESULTS: Sixty-one patients were randomised to mFOLFIRI.3 (n ¼ 31) or mFOLFOX (n ¼ 30) regimen. The six-month survival rates were 27% (95% confidence interval (CI) ¼ 13 -46%) and 30% (95% CI ¼ 15 -49%), respectively. The median overall survival periods were 16.6 and 14.9 weeks, respectively. Disease control was achieved in 23% (95% CI ¼ 10 -42%) and 17% patients (95% CI ¼ 6 -35%), respectively. The number of patients with at least one grade 3/4 toxicity was identical (11 patients, 38%) in both groups: neutropenia (7 patients under mFOLFIRI.3 regimen vs 6 patients under mFOLFOX regimen), asthaenia (1 vs 4), vomiting (3 in both), diarrhoea (2 vs 0), and mucositis (1 vs 2). CONCLUSION: Both mFOLFIRI.3 and mFOLFOX regimens were tolerated with manageable toxicity, offering modest activities as second-line treatments for patients with advanced pancreatic cancer, previously treated with gemcitabine.

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“…Toxicity was acceptable with few grade 3-4 adverse events. Median progression-free survival and overall survival were significantly better in the OFF arm (13 vs 9 weeks, p=0.012, and 26 vs 13 weeks, p=0.014, respectively) (Pelzer et al, 2008).…”

Section: Gemcitabine-resistant Diseasementioning

confidence: 99%

Current Perspectives and Future Trends of Systemic Therapy in Advanced Pancreatic Carcinoma

Estévez-García¹,

García‐Carbonero²

2012

Pancreatic Cancer - Clinical Management

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A randomized trial in patients with gemcitabine refractory pancreatic cancer. Final results of the CONKO 003 study

Cited by 101 publications

References 0 publications

Phase II study of palliative S-1 in combination with cisplatin as second-line chemotherapy for gemcitabine-refractory pancreatic cancer patients

Phase II study of palliative S-1 in combination with cisplatin as second-line chemotherapy for gemcitabine-refractory pancreatic cancer patients

A randomised phase II study of modified FOLFIRI.3 vs modified FOLFOX as second-line therapy in patients with gemcitabine-refractory advanced pancreatic cancer

Current Perspectives and Future Trends of Systemic Therapy in Advanced Pancreatic Carcinoma

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