INTRODUCTION: We undertook this phase II study to measure postoperative drug delivery and toxicity of cisplatin plus docetaxel in patients with resected stage I-III non-small cell lung cancer. METHODS: The primary endpoint was amount of cisplatin delivered over a planned four cycles of adjuvant chemotherapy. Statistical design required a cohort to close if the regimen proved unlikely to improve cisplatin delivery compared with published phase III data. The first cohort was treated with docetaxel 35 mg/m2 intravenously (IV) on days 1, 8, and 15, and cisplatin 80 mg/m2 IV on day 15, every 4 weeks for four planned cycles. A second cohort was treated with docetaxel 75 mg/m2 IV plus cisplatin 80 mg/m2 IV on day 1 every 3 weeks for four planned cycles. RESULTS:Sixteen patients were treated with weekly docetaxel and cisplatin every 4 weeks, with five of 16 (31%) unable to complete three cycles. Subsequently, 11 patients were treated with docetaxel and cisplatin every 3 weeks, with six of 11 (55%) unable to complete three cycles. Among the 11 patients who failed to complete three cycles, the reasons for stopping included one or more of the following: fatigue (n = 8), nausea (n = 4), febrile neutropenia (n = 1), hypotension (n = 1), and nephrotoxicity (n = 1). CONCLUSIONS: The combination of cisplatin at 80 mg/m2 with docetaxel 35 mg/m2 weekly or 75 mg/m2 every 3 weeks is no better tolerated than older chemotherapy regimens. The most common reason to stop chemotherapy was intolerable fatigue. These results suggest that the most common dose-limiting toxicities are attributable to the cisplatin, given similar problems were encountered whether the docetaxel was delivered as a single dose every 3 weeks or as a lower weekly dose.
RCT Entities:
INTRODUCTION: We undertook this phase II study to measure postoperative drug delivery and toxicity of cisplatin plus docetaxel in patients with resected stage I-III non-small cell lung cancer. METHODS: The primary endpoint was amount of cisplatin delivered over a planned four cycles of adjuvant chemotherapy. Statistical design required a cohort to close if the regimen proved unlikely to improve cisplatin delivery compared with published phase III data. The first cohort was treated with docetaxel 35 mg/m2 intravenously (IV) on days 1, 8, and 15, and cisplatin 80 mg/m2 IV on day 15, every 4 weeks for four planned cycles. A second cohort was treated with docetaxel 75 mg/m2 IV plus cisplatin 80 mg/m2 IV on day 1 every 3 weeks for four planned cycles. RESULTS: Sixteen patients were treated with weekly docetaxel and cisplatin every 4 weeks, with five of 16 (31%) unable to complete three cycles. Subsequently, 11 patients were treated with docetaxel and cisplatin every 3 weeks, with six of 11 (55%) unable to complete three cycles. Among the 11 patients who failed to complete three cycles, the reasons for stopping included one or more of the following: fatigue (n = 8), nausea (n = 4), febrile neutropenia (n = 1), hypotension (n = 1), and nephrotoxicity (n = 1). CONCLUSIONS: The combination of cisplatin at 80 mg/m2 with docetaxel 35 mg/m2 weekly or 75 mg/m2 every 3 weeks is no better tolerated than older chemotherapy regimens. The most common reason to stop chemotherapy was intolerable fatigue. These results suggest that the most common dose-limiting toxicities are attributable to the cisplatin, given similar problems were encountered whether the docetaxel was delivered as a single dose every 3 weeks or as a lower weekly dose.
Authors: K Kelly; J Crowley; P A Bunn; C A Presant; P K Grevstad; C M Moinpour; S D Ramsey; A J Wozniak; G R Weiss; D F Moore; V K Israel; R B Livingston; D R Gandara Journal: J Clin Oncol Date: 2001-07-01 Impact factor: 44.544
Authors: V Georgoulias; E Papadakis; A Alexopoulos; X Tsiafaki; A Rapti; M Veslemes; P Palamidas; I Vlachonikolis Journal: Lancet Date: 2001-05-12 Impact factor: 79.321
Authors: Joan H Schiller; David Harrington; Chandra P Belani; Corey Langer; Alan Sandler; James Krook; Junming Zhu; David H Johnson Journal: N Engl J Med Date: 2002-01-10 Impact factor: 91.245
Authors: S Ricci; A Antonuzzo; L Galli; C Tibaldi; M Bertuccelli; A Lopes Pegna; S Petruzzelli; V Bonifazi; C Orlandini; P Franco Conte Journal: Cancer Date: 2000-10-15 Impact factor: 6.860
Authors: Marc L Citron; Donald A Berry; Constance Cirrincione; Clifford Hudis; Eric P Winer; William J Gradishar; Nancy E Davidson; Silvana Martino; Robert Livingston; James N Ingle; Edith A Perez; John Carpenter; David Hurd; James F Holland; Barbara L Smith; Carolyn I Sartor; Eleanor H Leung; Jeffrey Abrams; Richard L Schilsky; Hyman B Muss; Larry Norton Journal: J Clin Oncol Date: 2003-02-13 Impact factor: 44.544
Authors: M Ychou; J-L Raoul; J-Y Douillard; S Gourgou-Bourgade; R Bugat; L Mineur; F Viret; Y Becouarn; O Bouché; E Gamelin; M Ducreux; T Conroy; J-F Seitz; L Bedenne; A Kramar Journal: Ann Oncol Date: 2009-01-29 Impact factor: 32.976
Authors: Frank Fossella; Jose R Pereira; Joachim von Pawel; Anna Pluzanska; Vera Gorbounova; Eckhard Kaukel; Karin V Mattson; Rodryg Ramlau; Aleksandra Szczesna; Panagiotis Fidias; Michael Millward; Chandra P Belani Journal: J Clin Oncol Date: 2003-07-01 Impact factor: 44.544
Authors: Sergio Poli-Bigelli; Jose Rodrigues-Pereira; Alexandra D Carides; Guoguang Julie Ma; Krista Eldridge; Anita Hipple; Judith K Evans; Kevin J Horgan; Francesca Lawson Journal: Cancer Date: 2003-06-15 Impact factor: 6.860
Authors: Ana Belén Custodio Carretero; José Angel García Sáenz; José Luis González Larriba; Jana Bobokova; Antonio Calles Blanco; Florentino Hernando Trancho; Beatriz García Paredes; Laura Rodríguez Lajusticia; Eduardo Díaz-Rubio García Journal: Clin Transl Oncol Date: 2008-09 Impact factor: 3.405
Authors: Jamie E Chaft; Natasha Rekhtman; Camelia S Sima; Valerie Rusch; Mark G Kris; Maureen Zakowski; Christopher G Azzoli Journal: Cancer Chemother Pharmacol Date: 2013-08-22 Impact factor: 3.333