Randomised phase II study of cisplatin and 5-fluorouracil (5-FU) versus cisplatin alone in advanced squamous cell oesophageal cancer

Bleiberg, Harry; Conroy, Thierry; Paillot, B; Lacave, A.J.; Blijham, Geert H.; Jacob, Jacques-Henri; Bedenne, Laurent; Namer, M.; Besi, P. De; Collette, Laurence; Sahmoud, Tarek

doi:10.1016/s0959-8049(97)00088-9

Cited by 301 publications

(188 citation statements)

References 14 publications

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“…Some authors [8] reported up to 16% of treatment-related deaths with the same combination, even using chemotherapy alone. In a randomized study in operable patients [3], using preoperative CT alone, we were able to deliver 68% of three planned cycles of FU/cisplatin.…”

Section: Discussionmentioning

confidence: 99%

“…BrieXy, oxaliplatin was administered as a 2-h infusion on days 1,8,15,29,37,43,50, 57 at a dose of 60 mg/m 2 , as previously established in our single-center phase I study, on rectal cancer [4], and was followed by leucovorin 20 mg/m 2 over 10Ј and a continuous infusion of Xuorouracil 200 mg/ m 2 per day over days 1-22 and 29-64. Patients received the planned treatment with no dose reduction if they had a neutrophil count¸1,500 l ¡1 and a platelet count¸100,000 l ¡1 ; otherwise chemotherapy was delayed until complete toxicity recovery. Treatment modiWcations were speciWed for hematological, gastrointestinal and neurological toxicity using the NCI Common Toxicity Criteria version 2.0.…”

Section: Chemotherapymentioning

confidence: 99%

“…Methods Fifty-nine patients with adeno or squamous-cell carcinoma received oxaliplatin (60 mg/m 2 ), and leucovorin (20 mg/m 2 on days 1, 8,15,29,36,43,50,57) followed by continuous infusion Xuorouracil (200 mg/m 2 per day on days 1-22 and 29-64) with radiotherapy (1.8 Gy daily fractions to a total dose of 45 Gy, from days 29 to 64). When feasible, surgery was scheduled 6-8 weeks after chemoradiotherapy completion.…”

Section: Introductionmentioning

confidence: 99%

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Multi-center phase II trial of chemo-radiotherapy with 5-fluorouracil, leucovorin and oxaliplatin in locally advanced esophageal cancer

Chiarion-Sileni

Innocente

Cavina³

et al. 2008

Cancer Chemother Pharmacol

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Purpose The aim of this study was to evaluate the activity and safety of oxaliplatin/5-Xuorouracil-based chemo-radiotherapy in patients with not radically resectable locally advanced esophageal cancer. Methods Fifty-nine patients with adeno or squamous-cell carcinoma received oxaliplatin (60 mg/m 2 ), and leucovorin (20 mg/m 2 on days 1, 8,15,29,36,43,50,57) followed by continuous infusion Xuorouracil (200 mg/m 2 per day on days 1-22 and 29-64) with radiotherapy (1.8 Gy daily fractions to a total dose of 45 Gy, from days 29 to 64). When feasible, surgery was scheduled 6-8 weeks after chemoradiotherapy completion. The primary endpoint was 1-year progression-free survival. Results Forty (68%) patients completed treatment without modiWcations. An objective clinical response was seen in 35 patients (59%). Esophagectomy was possible in 33 patients and a complete resection (R0) was achieved in 26 (79%) with 6 pathologic complete responses (pCR) and 3 near pCR.At a median follow-up of 39.7 months for the surviving patients, the median progression-free and overall survivals were 11 months (95% CI 6.5-14) and 18.5 months (95% CI 13-29). The 1-year progression-free and overall survivals were 47.5% (95% CI 34-59.5%) and 63% (95% CI 49-74%). Major toxicities were esophagitis (20% G3 and 5% G4) and diarrhea (8.5% G3 and 8.5% G4). Hematological toxicity (7% G3 and 3% G4) was less common; severe neurotoxicity (3% G3) was infrequent. Conclusions Concurrent oxaliplatin, leucovorin, Xuorouracil and radiotherapy followed or not by esophagectomy has a tolerable toxicity and promising activity in locally advanced esophageal cancer.

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Section: Discussionmentioning

confidence: 99%

Section: Chemotherapymentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Multi-center phase II trial of chemo-radiotherapy with 5-fluorouracil, leucovorin and oxaliplatin in locally advanced esophageal cancer

Chiarion-Sileni

Innocente

Cavina³

et al. 2008

Cancer Chemother Pharmacol

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“…Pre-operative treatment with this combination was tolerated well by patients with resectable disease in two large randomised trials Clark, 2000). However in one of the few randomised studies performed in patients with metastatic disease, the toxicity of this regimen appeared to be severe (Bleiberg et al, 1997). In that trial 88 patients with metastatic oesophageal cancer received either cisplatin in combination with 5-fluorouracil or cisplatin alone.…”

Section: Discussionmentioning

confidence: 99%

“…Combination chemotherapy with cisplatin and 5-fluorouracil and/or etoposide or with bleomycin and vindesine has predominantly been used in patients with squamous cell carcinoma (Kelsen et al, 1990;Kok et al, 1996;Bleiberg et al, 1997), yielding response rates of 45 -75% in patients with locoregional disease and 25 -35% in patients .…”

mentioning

confidence: 99%

Phase II study of bi-weekly administration of paclitaxel and cisplatin in patients with advanced oesophageal cancer

et al. 2002

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In a phase I study we demonstrated the feasibility of a bi-weekly combination of paclitaxel 180 mg m 72 with cisplatin 60 mg m 72 . In this study we further assessed toxicity and efficacy of this schedule in the treatment of advanced cancer of the oesophagus or the gastro-oesophageal junction. Patients received paclitaxel 180 mg m 72 administered over 3 h followed by a 3-h infusion of cisplatin 60 mg m 72 . Patients were retreated every 2 weeks unless granulocytes were 50.75610 9 or platelets 575610 9 . Patients were evaluated after three and six cycles and responding patients received a maximum of eight cycles. Fifty-one patients were enrolled into the study. The median age was 56 years (range 32 -78). WHO performance status were: 0 (19 patients); 1 (29 patients); 2 (three patients). All patients received at least three cycles of chemotherapy and all were evaluable for toxicity and response. Haematological toxicity consisted of uncomplicated neutropenia grade 3 in 39% and grade 4 in 31% of patients. Five patients (10%) were hospitalised, three patients because of treatment related complications and two patients because of infections without neutropenia. Sensory neurotoxicity was the predominant non-haematological toxicity; grade 1 and 2 neurotoxicity was observed in 43 and 20% of patients, respectively. Response evaluation in 51 patients with measurable disease: complete response 4%, partial response 39%, stable disease 43% and progressive disease in 14% of the patients. The median duration of response was 8 months. The median survival for all patients was 9 (range 2 -29+) months and the one-year survival rate was 43%. Four patients who received additional local treatment (two patients surgery and two patients radiotherapy) are still disease free after a follow-up of 20 -29 months. This bi-weekly treatment of paclitaxel and cisplatin is well tolerated by patients with advanced oesophageal cancer. The toxicity profile of this regimen compares favourable to that of previously used cisplatin-and paclitaxel-based regimens. Trials are underway evaluating this bi-weekly regimen in a neo-adjuvant setting.

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Chemotherapy for metastatic carcinoma of the esophagus and gastro-esophageal junction

Homs

Gaast

Siersema

et al. 2006

Cochrane Database of Systematic Reviews

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There is a need for well designed, adequately powered, phase III trials comparing chemotherapy versus best supportive care for patients with metastatic esophageal cancer. Chemotherapy agents with promising response rates and tolerable toxicity are cisplatin, 5-fluorouracil (5-FU), paclitaxel and antracyclins. Future trials comparing palliative treatment modalities should assess quality of life with validated quality of life measures.

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Randomised phase II study of cisplatin and 5-fluorouracil (5-FU) versus cisplatin alone in advanced squamous cell oesophageal cancer

Cited by 301 publications

References 14 publications

Multi-center phase II trial of chemo-radiotherapy with 5-fluorouracil, leucovorin and oxaliplatin in locally advanced esophageal cancer

Multi-center phase II trial of chemo-radiotherapy with 5-fluorouracil, leucovorin and oxaliplatin in locally advanced esophageal cancer

Phase II study of bi-weekly administration of paclitaxel and cisplatin in patients with advanced oesophageal cancer

Chemotherapy for metastatic carcinoma of the esophagus and gastro-esophageal junction

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