Phase II trial of alternating intravenous and oral vinorelbine in combination with cisplatin in advanced non-small cell lung cancer

Elisabetta Campagnoli, Isabella Garassino, Armando Santoro, Fabio De Vincenzo, Paolo Andrea Zucali, Giovanni Luca Ceresoli, Fabio Romano Lutman, Marco Alloisio, Hector Josè Soto Parra, Raffaele Cavina

Research output: Contribution to journalArticle

Abstract

Cisplatin-based chemotherapy is the standard treatment for advanced non-small cell lung cancer (NSCLC). Several platinum-based doublets have been tested in phase II/III trials with equivalent results in terms of tumour response and survival. Our study was designed to evaluate activity, tolerability and convenience of alternating intravenous (i.v.) and oral vinorelbine in combination with cisplatin in advanced NSCLC. Forty chemo-naive patients with stage IV or relapsed unresectable disease and good performance status were enrolled to receive i.v. cisplatin 40 mg/m2 on days 1 and 2 plus i.v. vinorelbine 25 mg/m2 on day 1, every 3 weeks. Oral vinorelbine 60 mg/m2 was given at home on day 5, without checking of blood cell count. A total of 175 treatment cycles were delivered. The overall response rate was 30% (one complete, 11 partial responses). Median time to progression and overall survival were 5 and 10 months, respectively. The main toxicity was haematological, with grade 3-4 neutropenia observed in 75% of patients, without febrile neutropenia. Non-haematological toxicity was mild. This schedule of cisplatin and vinorelbine treatment showed a good toxicity profile and an efficacy similar to other standard regimens. Oral vinorelbine could be administered safely at home on day 5.

Original languageEnglish
Pages (from-to)559-564
Number of pages6
JournalInvestigational New Drugs
Volume25
Issue number6
DOIs
Publication statusPublished - Dec 2007

Fingerprint

Non-Small Cell Lung Carcinoma
Cisplatin
Febrile Neutropenia
Survival
Blood Cell Count
Neutropenia
Platinum
Appointments and Schedules
Therapeutics
vinorelbine
Drug Therapy
Neoplasms

Keywords

  • Advanced NSCLC
  • Cisplatin
  • Oral chemotherapy
  • Oral vinorelbine

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)
  • Oncology
  • Molecular Medicine

Cite this

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title = "Phase II trial of alternating intravenous and oral vinorelbine in combination with cisplatin in advanced non-small cell lung cancer",
abstract = "Cisplatin-based chemotherapy is the standard treatment for advanced non-small cell lung cancer (NSCLC). Several platinum-based doublets have been tested in phase II/III trials with equivalent results in terms of tumour response and survival. Our study was designed to evaluate activity, tolerability and convenience of alternating intravenous (i.v.) and oral vinorelbine in combination with cisplatin in advanced NSCLC. Forty chemo-naive patients with stage IV or relapsed unresectable disease and good performance status were enrolled to receive i.v. cisplatin 40 mg/m2 on days 1 and 2 plus i.v. vinorelbine 25 mg/m2 on day 1, every 3 weeks. Oral vinorelbine 60 mg/m2 was given at home on day 5, without checking of blood cell count. A total of 175 treatment cycles were delivered. The overall response rate was 30{\%} (one complete, 11 partial responses). Median time to progression and overall survival were 5 and 10 months, respectively. The main toxicity was haematological, with grade 3-4 neutropenia observed in 75{\%} of patients, without febrile neutropenia. Non-haematological toxicity was mild. This schedule of cisplatin and vinorelbine treatment showed a good toxicity profile and an efficacy similar to other standard regimens. Oral vinorelbine could be administered safely at home on day 5.",
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author = "Elisabetta Campagnoli and Isabella Garassino and Armando Santoro and {De Vincenzo}, Fabio and Zucali, {Paolo Andrea} and Ceresoli, {Giovanni Luca} and Lutman, {Fabio Romano} and Marco Alloisio and {Soto Parra}, {Hector Jos{\`e}} and Raffaele Cavina",
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T1 - Phase II trial of alternating intravenous and oral vinorelbine in combination with cisplatin in advanced non-small cell lung cancer

AU - Campagnoli, Elisabetta

AU - Garassino, Isabella

AU - Santoro, Armando

AU - De Vincenzo, Fabio

AU - Zucali, Paolo Andrea

AU - Ceresoli, Giovanni Luca

AU - Lutman, Fabio Romano

AU - Alloisio, Marco

AU - Soto Parra, Hector Josè

AU - Cavina, Raffaele

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N2 - Cisplatin-based chemotherapy is the standard treatment for advanced non-small cell lung cancer (NSCLC). Several platinum-based doublets have been tested in phase II/III trials with equivalent results in terms of tumour response and survival. Our study was designed to evaluate activity, tolerability and convenience of alternating intravenous (i.v.) and oral vinorelbine in combination with cisplatin in advanced NSCLC. Forty chemo-naive patients with stage IV or relapsed unresectable disease and good performance status were enrolled to receive i.v. cisplatin 40 mg/m2 on days 1 and 2 plus i.v. vinorelbine 25 mg/m2 on day 1, every 3 weeks. Oral vinorelbine 60 mg/m2 was given at home on day 5, without checking of blood cell count. A total of 175 treatment cycles were delivered. The overall response rate was 30% (one complete, 11 partial responses). Median time to progression and overall survival were 5 and 10 months, respectively. The main toxicity was haematological, with grade 3-4 neutropenia observed in 75% of patients, without febrile neutropenia. Non-haematological toxicity was mild. This schedule of cisplatin and vinorelbine treatment showed a good toxicity profile and an efficacy similar to other standard regimens. Oral vinorelbine could be administered safely at home on day 5.

AB - Cisplatin-based chemotherapy is the standard treatment for advanced non-small cell lung cancer (NSCLC). Several platinum-based doublets have been tested in phase II/III trials with equivalent results in terms of tumour response and survival. Our study was designed to evaluate activity, tolerability and convenience of alternating intravenous (i.v.) and oral vinorelbine in combination with cisplatin in advanced NSCLC. Forty chemo-naive patients with stage IV or relapsed unresectable disease and good performance status were enrolled to receive i.v. cisplatin 40 mg/m2 on days 1 and 2 plus i.v. vinorelbine 25 mg/m2 on day 1, every 3 weeks. Oral vinorelbine 60 mg/m2 was given at home on day 5, without checking of blood cell count. A total of 175 treatment cycles were delivered. The overall response rate was 30% (one complete, 11 partial responses). Median time to progression and overall survival were 5 and 10 months, respectively. The main toxicity was haematological, with grade 3-4 neutropenia observed in 75% of patients, without febrile neutropenia. Non-haematological toxicity was mild. This schedule of cisplatin and vinorelbine treatment showed a good toxicity profile and an efficacy similar to other standard regimens. Oral vinorelbine could be administered safely at home on day 5.

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KW - Cisplatin

KW - Oral chemotherapy

KW - Oral vinorelbine

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