Phase II trial of paclitaxel, fluorouracil, and cisplatin in patients with advanced carcinoma of the esophagus.

Ilson, David H.; Ajani, Jaffer A.; Bhalla, Kapil N.; Forastiere, Arlene A.; Huang, Ying; Patel, Paresh; Martin, L.; Donegan, J. Oliver; Pazdur, Richard; Reed, Carolyn E.; Kelsen, David P.

doi:10.1200/jco.1998.16.5.1826

Cited by 208 publications

(137 citation statements)

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“…A similar favourable response rate of 51% with a median survival time of 6 months was recently achieved by Kim et al (1999) administering paclitaxel at a dose of 175 mg/m 2 on day 1, 5-FU at a dose of 750 mg/m 2 on days 1-5 as continuous infusion and cisplatin at a dose of 20 mg/m 2 as a 30 minute infusion on days 1-5. In patients with adenocarcinoma of the oesophagus, Ilson et al (1998) reported a response rate of 46% with a similar schedule. The median overall and progression-free survival of 14 and 9 months duration, respectively, in the current study are encouraging.…”

Section: Discussionmentioning

confidence: 98%

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A phase II study of paclitaxel, weekly, 24-hour continuous infusion 5-fluorouracil, folinic acid and cisplatin in patients with advanced gastric cancer

et al. 2000

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SummaryTo evaluate the toxicity and efficacy of combination chemotherapy with paclitaxel, cisplatin and 24 h continuous infusion of 5-FU/folinic acid in patients (pts) with unresectable, locally advanced or metastatic gastric adenocarcinoma. Forty-five chemotherapy-naive pts (28 male and 17 female) with a median age of 60 years (range 35-74) were enrolled. 5-FU 2 g/m 2 was given weekly over 24 h i.v. preceded by folinic acid 500 mg/m 2 as a 2 h infusion. Paclitaxel 175 mg/m 2 was administered as a 3 h-infusion on days 1 and 22 and cisplatin 50 mg/m 2 as 1 h infusion on days 8 and 29. Six weeks of therapy (days 1, 8, 15, 22, 29, 36) followed by 2 weeks rest were considered one cycle. A median of 3 cycles (range 1-4) were administered to 45 pts assessable for response, survival and toxicity. Five pts (11%) obtained a CR and 18 pts (40%) a PR (ORR 51%; 95% Cl: 35.8-66.3%). Responses were achieved in the liver, lymph nodes, lungs and at the site of the primary tumour. Nine pts (20%) had stable disease. Thirteen pts (29%) were considered to have failed treatment, 8 pts (18%) due to progressive disease and 5 pts (11%) who did not receive one complete cycle of therapy due to acute non-haematologic toxicity. The median progression-free and overall survival times were 9 months (range 1-36+) and 14 months (range 2-36+), respectively. Neutropenia WHO III°/IV°occurred in 7 pts (15%) with only 1 pt having grade IV. Additional non-haematologic WHO III°/IV°toxicities included nausea/vomiting in 5 (11%), alopecia in 22 (49%), and diarrhoea in 1 patient each (2%). Dose reductions or treatment delays were necessary in 8 pts (17%), mainly due to neutropenia. All pts were treated on an outpatient basis. The combination of paclitaxel, cisplatin and continuously infused 5-FU/folinic acid appears to be a highly active regimen for the treatment of pts with advanced gastric cancer. While the overall acceptable toxicity allows its use in the palliative setting, it may also be an attractive option to be tested for neoadjuvant or adjuvant treatment.

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Section: Discussionmentioning

confidence: 98%

“…A high response rate combined with an acceptable toxicity was reported (Belani et al, 1997;Ilson et al, 1998).…”

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confidence: 99%

A phase II study of paclitaxel, weekly, 24-hour continuous infusion 5-fluorouracil, folinic acid and cisplatin in patients with advanced gastric cancer

et al. 2000

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“…Ilson et al (1998) treated 61 patients with the combination of paclitaxel 175 mg m 72 administered over 3 h on day 1, cisplatin 20 mg m 72 days 1 -5 and 5-fluorouracil 1000 mg m 72 days 1 -5; 48% of the patients had to be admitted for reasons of toxicity. In a subsequent study 5-fluorouracil was omitted and paclitaxel 200 -250 mg m 72 was administered over 24 h followed by cisplatin 75 mg m 72 (Ilson et al, 2000). Cycles were repeated every 3 weeks and all patients received granulocyte colony stimulating factor support.…”

Section: Clinicalmentioning

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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“…Thus, there is a need for tolerable and active protocols beyond cisplatin-based therapy. Irinotecan and taxanes proved to induce remissions in oesophageal cancer (Ilson et al, 1998(Ilson et al, , 1999 although single-agent docetaxel revealed only moderate activity (Heath et al, 2002). The combination of irinotecan and docetaxel has been investigated in phase I studies in patients with pretreated solid tumours (Adjei et al, 2000;Couteau et al, 2000).…”

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confidence: 99%

Phase II trial of irinotecan plus docetaxel in cisplatin-pretreated relapsed or refractory oesophageal cancer

et al. 2003

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This phase II trial assessed the toxicity and efficacy of irinotecan plus docetaxel in cisplatin-pretreated oesophageal cancer. Irinotecan 160 mg m À2 plus docetaxel 65 mg m À2 once every 3 weeks led to severe myelosuppression in four patients, all of whom experienced neutropenic fever. After amendment of this regimen, 24 patients (male/female ¼ 18/6; median age ¼ 58.5 years; ECOG performance status 0/1/2 ¼ 9/11/4) with advanced oesophageal cancer (adenocarcinoma/epidermoid carcinoma ¼ 13/11) received irinotecan 55 mg m À2 plus docetaxel 25 mg m À2 on days 1, 8 and 15 of a 28-day cycle. Serious adverse events occurred in five patients, one with lethal outcome (pneumonia). Haematological toxicity X31 was rare, whereas nonhaematological toxicity X31 was noted in nine out of 24 patients (asthenia in five patients, diarrhoea in three patients, nausea/emesis in two patients, constipation in one patient). Median survival time was 26 (range 2 -70) weeks. Response rate, assessed according to the WHO criteria, was 12.5% (95% CI 2.7 -32.4%); rate of disease stabilisation (partial remission and stable disease) was 33.3% (95% CI 15.6 -55.3%) with a median duration of 18.5 (range 16 -51) weeks. Although the nonhaematological toxicity proved to be considerable, weekly irinotecan plus docetaxel is feasible and shows some activity in extensively pretreated patients with oesophageal cancer. British Journal of Cancer (2003) Owing to early lymphogenic and haematogenous spread, most patients with oesophageal cancer are diagnosed with advanced disease. These patients receive multimodal treatment if the tumour is deemed to be resectable, or systemic chemotherapy if palliation is the goal. Cisplatin has been the mainstay of chemotherapy and chemoradiotherapy protocols during the last decade (Herskovic et al, 1992;Bleiberg et al, 1997). In case of resistance to cisplatin-based therapy, no evidence-based recommendations regarding second-line treatment exist, but many patients ask for more than measures of best supportive care. Thus, there is a need for tolerable and active protocols beyond cisplatin-based therapy. Irinotecan and taxanes proved to induce remissions in oesophageal cancer (Ilson et al, 1998(Ilson et al, , 1999 although single-agent docetaxel revealed only moderate activity (Heath et al, 2002). The combination of irinotecan and docetaxel has been investigated in phase I studies in patients with pretreated solid tumours (Adjei et al, 2000;Couteau et al, 2000). The recommended phase II dose on this schedule was irinotecan 160 mg m À2 followed by docetaxel 65 mg m À2 administered every 3 weeks (Adjei et al, 2000). This phase II trial was designed to assess the activity and toxicity of the combination of irinotecan plus docetaxel in cisplatin-pretreated relapsed or refractory oesophageal cancer. METHODS Patient populationPatients with histologically confirmed adenocarcinoma or epidermoid carcinoma of the oesophagus were enrolled at a single site (Klinikum rechts der Isar, Technical University of Munich). Eligible patients with...

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Phase II trial of paclitaxel, fluorouracil, and cisplatin in patients with advanced carcinoma of the esophagus.

Cited by 208 publications

References 12 publications

A phase II study of paclitaxel, weekly, 24-hour continuous infusion 5-fluorouracil, folinic acid and cisplatin in patients with advanced gastric cancer

A phase II study of paclitaxel, weekly, 24-hour continuous infusion 5-fluorouracil, folinic acid and cisplatin in patients with advanced gastric cancer

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

Phase II trial of irinotecan plus docetaxel in cisplatin-pretreated relapsed or refractory oesophageal cancer

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