Phase II study of paclitaxel in pretreated advanced gastric cancer

Cascinu, Stefano; Graziano, Francesco; Cardarelli, Nadia; Marcellini, Massimo; Giordani, Paolo; Menichetti, Ettore Tito; Catalano, Giuseppina

doi:10.1097/00001813-199804000-00003

Cited by 93 publications

(65 citation statements)

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“…This is comparable with the median overall survival times achieved with taxane monotherapy and other combination regimens, including FAMTX (7 months) and ECF (8.5 months) [6,14,15,25].…”

Section: Discussionsupporting

confidence: 67%

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Docetaxel, 5-fluorouracil, and leucovorin as treatment for advanced gastric cancer: results of a phase II study

et al. 2002

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“…This is comparable with the median overall survival times achieved with taxane monotherapy and other combination regimens, including FAMTX (7 months) and ECF (8.5 months) [6,14,15,25].…”

Section: Discussionsupporting

confidence: 67%

“…In two separate studies of single-agent docetaxel at a dose of 60 mg/m 2 as a 1-h intravenous infusion every 3-4 weeks, the ORR achieved in both was 24% [22,23]. Similarly, ORRs of 8%-23% were reported in studies of paclitaxel as a single agent [24][25][26][27].…”

Section: Discussionmentioning

confidence: 98%

Docetaxel, 5-fluorouracil, and leucovorin as treatment for advanced gastric cancer: results of a phase II study

et al. 2002

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“…In vitro and in vivo data appear to support the use of paclitaxel in gastric cancer (Chang et al, 1996;Ajani et al, 1998;Cascinu et al, 1998). An additive cytotoxic effect has been reported in vitro for the sequence of paclitaxel followed by 5-FU whereas the exposure to 5-FU followed by paclitaxel showed subadditive effects (Kano et al, 1996).…”

Section: Discussionmentioning

confidence: 91%

“…Ajani et al obtained a 17% response rate using paclitaxel as a single agent in gastric cancer, with a tendency towards a higher response rate in patients receiving paclitaxel as continuous infusion over 24 hours. A 22% response rate was observed in pretreated patients with gastric cancer by Cascinu et al, with paclitaxel as single agent administered over 3 hours Cascinu et al, 1998). Studies investigating the combination of paclitaxel with 5-FU revealed response rates between 15 and 50%, associated with a rather low toxicity profile (Cascinu et al, 1997;Murad, 1999).…”

mentioning

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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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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“…The second reason for combining paclitaxel with 5-FU is that their principal toxicities differ considerably. Neuropathy and neutropenia are the principal toxicities of paclitaxel, whereas stomatitis and diarrhoea are the predominant toxicities of fluoropyrimidines in most commonly used regimens (Bokemeyer et al, 1997;Cascinu et al, 1998). We therefore combined paclitaxel with S-1.…”

Section: Discussionmentioning

confidence: 99%

Phase I/II study of S-1 combined with paclitaxel in patients with unresectable and/or recurrent advanced gastric cancer

et al. 2006

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Both paclitaxel and S-1 are effective against gastric cancer, but the optimal regimen for combined chemotherapy with these drugs remains unclear. This phase I/II study was designed to determine the maximum tolerated dose (MTD), recommended dose (RD), dose-limiting toxicity (DLT), and objective response rate of paclitaxel in combination with S-1. S-1 was administered orally at a fixed dose of 80 mg m À2 day À1 from days 1 to 14 of a 28-day cycle. Paclitaxel was given intravenously on days 1, 8, and 15, starting with a dose of 40 mg m À2 day À1 . The dose was increased in a stepwise manner to 70 mg m À2 . Treatment was repeated every 4 weeks unless disease progression was confirmed. In the phase I portion, 17 patients were enrolled. The MTD of paclitaxel was estimated to be 70 mg m À2 because 40% of the patients given this dose level (two of five) had DLT. The RD was determined to be 60 mg m À2 . In the phase II portion, 24 patients, including five with assessable disease who received the RD in the phase I portion, were evaluated. The median number of treatment courses was six (range: 1 -17). The incidence of the worst-grade toxicity in patients given the RD was 28 and 8%, respectively. All toxic effects were manageable. The response rate was 54.1%, and the median survival time was 15.5 months. Our phase I/II trial showed that S-1 combined with paclitaxel is effective and well tolerated in patients with advanced gastric cancer.

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Phase II study of paclitaxel in pretreated advanced gastric cancer

Cited by 93 publications

References 0 publications

Docetaxel, 5-fluorouracil, and leucovorin as treatment for advanced gastric cancer: results of a phase II study

Docetaxel, 5-fluorouracil, and leucovorin as treatment for advanced gastric cancer: results of a phase II study

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

Phase I/II study of S-1 combined with paclitaxel in patients with unresectable and/or recurrent advanced gastric cancer

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