Oral vinorelbine plus cisplatin as first-line chemotherapy in nonsquamous non-small-cell lung cancer: Final results of an international randomized phase II study (NAVotrial 01)

Jaafar Bennouna, Libor Havel, Maciej Krzakowski, Jens Kollmeier, Radj Gervais, Eric Dansin, Monika Serke, Adolfo Favaretto, Aleksandra Szczesna, Manuel Cobo, Libero Ciuffreda, Jacek Jassem, Mario Nicolini, Rodryg Ramlau, Domenico Amoroso, Barbara Melotti, Teresa Almodovar, Marcello Riggi, Noël Raphaël Caux, Nathalie VaissièreEng Huat Tan

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Abstract

Background The combination of oral vinorelbine plus cisplatin has been studied in numerous trials as first-line treatment of patients with non-small cell lung cancer (NSCLC) regardless of histologic subtype. NAVoTrial 01 is the first study that explores this combination specifically in nonsquamous (NS) NSCLC by assessing the feasibility of this doublet (ratio 1:2) in an investigational approach. A reference arm with pemetrexed plus cisplatin was included. Maintenance therapy with single-agent therapy after 4 cycles of combination therapy was included in the study schedules because it reflected a trend in first-line treatment of NSCLC. Patients and Methods Stage IIIB/IV untreated/relapsed patients with NS NSCLC received a 3-week cycle of pemetrexed 500 mg/m and cisplatin 75 mg/m on day 1 (arm A) or oral vinorelbine 80 mg/m on days 1 and 8 (first cycle 60 mg/m) and cisplatin 80 mg/m on day 1 (arm B). After 4 cycles, patients without disease progression received single-agent maintenance treatment with pemetrexed or oral vinorelbine. Results Overall, 153 patients were randomized (arm A/arm B: 51/102). Disease control rate (%) for arm A was 76.5 (95% confidence interval [CI], 62.5-87.2) and for arm B it was 75.0 (95% CI, 65.3-83.1), Response rates for arm A were 31.4% (95% CI, 19.1-45.9) and for arm B were 24.0% (95% CI, 16.0-33.6). Median progression-free survival for arm A was 4.3 months (95% CI, 3.8-5.6) and for arm B it was 4.2 months (95% CI, 3.6-4.7). Median survival for arm A was 10.8 months (95% CI, 7.0-16.4) and for arm B it was 10.2 months (95% CI, 7.8-11.9). Main grade 3/4 hematologic toxicities were neutropenia 18.3% (arm A) and 44.0% (arm B), whereas febrile neutropenia was reported in 2% of patients in each arm. Conclusion Oral vinorelbine and cisplatin had an efficacy in line with that achieved with a standard treatment such as pemetrexed and cisplatin, coupled with an acceptable safety profile.

Original languageEnglish
Pages (from-to)258-265
Number of pages8
JournalClinical Lung Cancer
Volume15
Issue number4
DOIs
Publication statusPublished - 2014

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Non-Small Cell Lung Carcinoma
Cisplatin
Pemetrexed
Confidence Intervals
Drug Therapy
Therapeutics
Febrile Neutropenia
vinorelbine
Neutropenia
Disease-Free Survival
Disease Progression
Appointments and Schedules
Safety
Survival

Keywords

  • Advanced non-small-cell lung cancer
  • Chemotherapy
  • Nonsquamous histologic subtype
  • Pemetrexed
  • Vinorelbine

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Pulmonary and Respiratory Medicine
  • Medicine(all)

Cite this

Oral vinorelbine plus cisplatin as first-line chemotherapy in nonsquamous non-small-cell lung cancer : Final results of an international randomized phase II study (NAVotrial 01). / Bennouna, Jaafar; Havel, Libor; Krzakowski, Maciej; Kollmeier, Jens; Gervais, Radj; Dansin, Eric; Serke, Monika; Favaretto, Adolfo; Szczesna, Aleksandra; Cobo, Manuel; Ciuffreda, Libero; Jassem, Jacek; Nicolini, Mario; Ramlau, Rodryg; Amoroso, Domenico; Melotti, Barbara; Almodovar, Teresa; Riggi, Marcello; Caux, Noël Raphaël; Vaissière, Nathalie; Tan, Eng Huat.

In: Clinical Lung Cancer, Vol. 15, No. 4, 2014, p. 258-265.

Research output: Contribution to journalArticle

Bennouna, J, Havel, L, Krzakowski, M, Kollmeier, J, Gervais, R, Dansin, E, Serke, M, Favaretto, A, Szczesna, A, Cobo, M, Ciuffreda, L, Jassem, J, Nicolini, M, Ramlau, R, Amoroso, D, Melotti, B, Almodovar, T, Riggi, M, Caux, NR, Vaissière, N & Tan, EH 2014, 'Oral vinorelbine plus cisplatin as first-line chemotherapy in nonsquamous non-small-cell lung cancer: Final results of an international randomized phase II study (NAVotrial 01)', Clinical Lung Cancer, vol. 15, no. 4, pp. 258-265. https://doi.org/10.1016/j.cllc.2014.04.007
Bennouna, Jaafar ; Havel, Libor ; Krzakowski, Maciej ; Kollmeier, Jens ; Gervais, Radj ; Dansin, Eric ; Serke, Monika ; Favaretto, Adolfo ; Szczesna, Aleksandra ; Cobo, Manuel ; Ciuffreda, Libero ; Jassem, Jacek ; Nicolini, Mario ; Ramlau, Rodryg ; Amoroso, Domenico ; Melotti, Barbara ; Almodovar, Teresa ; Riggi, Marcello ; Caux, Noël Raphaël ; Vaissière, Nathalie ; Tan, Eng Huat. / Oral vinorelbine plus cisplatin as first-line chemotherapy in nonsquamous non-small-cell lung cancer : Final results of an international randomized phase II study (NAVotrial 01). In: Clinical Lung Cancer. 2014 ; Vol. 15, No. 4. pp. 258-265.
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title = "Oral vinorelbine plus cisplatin as first-line chemotherapy in nonsquamous non-small-cell lung cancer: Final results of an international randomized phase II study (NAVotrial 01)",
abstract = "Background The combination of oral vinorelbine plus cisplatin has been studied in numerous trials as first-line treatment of patients with non-small cell lung cancer (NSCLC) regardless of histologic subtype. NAVoTrial 01 is the first study that explores this combination specifically in nonsquamous (NS) NSCLC by assessing the feasibility of this doublet (ratio 1:2) in an investigational approach. A reference arm with pemetrexed plus cisplatin was included. Maintenance therapy with single-agent therapy after 4 cycles of combination therapy was included in the study schedules because it reflected a trend in first-line treatment of NSCLC. Patients and Methods Stage IIIB/IV untreated/relapsed patients with NS NSCLC received a 3-week cycle of pemetrexed 500 mg/m and cisplatin 75 mg/m on day 1 (arm A) or oral vinorelbine 80 mg/m on days 1 and 8 (first cycle 60 mg/m) and cisplatin 80 mg/m on day 1 (arm B). After 4 cycles, patients without disease progression received single-agent maintenance treatment with pemetrexed or oral vinorelbine. Results Overall, 153 patients were randomized (arm A/arm B: 51/102). Disease control rate ({\%}) for arm A was 76.5 (95{\%} confidence interval [CI], 62.5-87.2) and for arm B it was 75.0 (95{\%} CI, 65.3-83.1), Response rates for arm A were 31.4{\%} (95{\%} CI, 19.1-45.9) and for arm B were 24.0{\%} (95{\%} CI, 16.0-33.6). Median progression-free survival for arm A was 4.3 months (95{\%} CI, 3.8-5.6) and for arm B it was 4.2 months (95{\%} CI, 3.6-4.7). Median survival for arm A was 10.8 months (95{\%} CI, 7.0-16.4) and for arm B it was 10.2 months (95{\%} CI, 7.8-11.9). Main grade 3/4 hematologic toxicities were neutropenia 18.3{\%} (arm A) and 44.0{\%} (arm B), whereas febrile neutropenia was reported in 2{\%} of patients in each arm. Conclusion Oral vinorelbine and cisplatin had an efficacy in line with that achieved with a standard treatment such as pemetrexed and cisplatin, coupled with an acceptable safety profile.",
keywords = "Advanced non-small-cell lung cancer, Chemotherapy, Nonsquamous histologic subtype, Pemetrexed, Vinorelbine",
author = "Jaafar Bennouna and Libor Havel and Maciej Krzakowski and Jens Kollmeier and Radj Gervais and Eric Dansin and Monika Serke and Adolfo Favaretto and Aleksandra Szczesna and Manuel Cobo and Libero Ciuffreda and Jacek Jassem and Mario Nicolini and Rodryg Ramlau and Domenico Amoroso and Barbara Melotti and Teresa Almodovar and Marcello Riggi and Caux, {No{\"e}l Rapha{\"e}l} and Nathalie Vaissi{\`e}re and Tan, {Eng Huat}",
year = "2014",
doi = "10.1016/j.cllc.2014.04.007",
language = "English",
volume = "15",
pages = "258--265",
journal = "Clinical Lung Cancer",
issn = "1525-7304",
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number = "4",

}

TY - JOUR

T1 - Oral vinorelbine plus cisplatin as first-line chemotherapy in nonsquamous non-small-cell lung cancer

T2 - Final results of an international randomized phase II study (NAVotrial 01)

AU - Bennouna, Jaafar

AU - Havel, Libor

AU - Krzakowski, Maciej

AU - Kollmeier, Jens

AU - Gervais, Radj

AU - Dansin, Eric

AU - Serke, Monika

AU - Favaretto, Adolfo

AU - Szczesna, Aleksandra

AU - Cobo, Manuel

AU - Ciuffreda, Libero

AU - Jassem, Jacek

AU - Nicolini, Mario

AU - Ramlau, Rodryg

AU - Amoroso, Domenico

AU - Melotti, Barbara

AU - Almodovar, Teresa

AU - Riggi, Marcello

AU - Caux, Noël Raphaël

AU - Vaissière, Nathalie

AU - Tan, Eng Huat

PY - 2014

Y1 - 2014

N2 - Background The combination of oral vinorelbine plus cisplatin has been studied in numerous trials as first-line treatment of patients with non-small cell lung cancer (NSCLC) regardless of histologic subtype. NAVoTrial 01 is the first study that explores this combination specifically in nonsquamous (NS) NSCLC by assessing the feasibility of this doublet (ratio 1:2) in an investigational approach. A reference arm with pemetrexed plus cisplatin was included. Maintenance therapy with single-agent therapy after 4 cycles of combination therapy was included in the study schedules because it reflected a trend in first-line treatment of NSCLC. Patients and Methods Stage IIIB/IV untreated/relapsed patients with NS NSCLC received a 3-week cycle of pemetrexed 500 mg/m and cisplatin 75 mg/m on day 1 (arm A) or oral vinorelbine 80 mg/m on days 1 and 8 (first cycle 60 mg/m) and cisplatin 80 mg/m on day 1 (arm B). After 4 cycles, patients without disease progression received single-agent maintenance treatment with pemetrexed or oral vinorelbine. Results Overall, 153 patients were randomized (arm A/arm B: 51/102). Disease control rate (%) for arm A was 76.5 (95% confidence interval [CI], 62.5-87.2) and for arm B it was 75.0 (95% CI, 65.3-83.1), Response rates for arm A were 31.4% (95% CI, 19.1-45.9) and for arm B were 24.0% (95% CI, 16.0-33.6). Median progression-free survival for arm A was 4.3 months (95% CI, 3.8-5.6) and for arm B it was 4.2 months (95% CI, 3.6-4.7). Median survival for arm A was 10.8 months (95% CI, 7.0-16.4) and for arm B it was 10.2 months (95% CI, 7.8-11.9). Main grade 3/4 hematologic toxicities were neutropenia 18.3% (arm A) and 44.0% (arm B), whereas febrile neutropenia was reported in 2% of patients in each arm. Conclusion Oral vinorelbine and cisplatin had an efficacy in line with that achieved with a standard treatment such as pemetrexed and cisplatin, coupled with an acceptable safety profile.

AB - Background The combination of oral vinorelbine plus cisplatin has been studied in numerous trials as first-line treatment of patients with non-small cell lung cancer (NSCLC) regardless of histologic subtype. NAVoTrial 01 is the first study that explores this combination specifically in nonsquamous (NS) NSCLC by assessing the feasibility of this doublet (ratio 1:2) in an investigational approach. A reference arm with pemetrexed plus cisplatin was included. Maintenance therapy with single-agent therapy after 4 cycles of combination therapy was included in the study schedules because it reflected a trend in first-line treatment of NSCLC. Patients and Methods Stage IIIB/IV untreated/relapsed patients with NS NSCLC received a 3-week cycle of pemetrexed 500 mg/m and cisplatin 75 mg/m on day 1 (arm A) or oral vinorelbine 80 mg/m on days 1 and 8 (first cycle 60 mg/m) and cisplatin 80 mg/m on day 1 (arm B). After 4 cycles, patients without disease progression received single-agent maintenance treatment with pemetrexed or oral vinorelbine. Results Overall, 153 patients were randomized (arm A/arm B: 51/102). Disease control rate (%) for arm A was 76.5 (95% confidence interval [CI], 62.5-87.2) and for arm B it was 75.0 (95% CI, 65.3-83.1), Response rates for arm A were 31.4% (95% CI, 19.1-45.9) and for arm B were 24.0% (95% CI, 16.0-33.6). Median progression-free survival for arm A was 4.3 months (95% CI, 3.8-5.6) and for arm B it was 4.2 months (95% CI, 3.6-4.7). Median survival for arm A was 10.8 months (95% CI, 7.0-16.4) and for arm B it was 10.2 months (95% CI, 7.8-11.9). Main grade 3/4 hematologic toxicities were neutropenia 18.3% (arm A) and 44.0% (arm B), whereas febrile neutropenia was reported in 2% of patients in each arm. Conclusion Oral vinorelbine and cisplatin had an efficacy in line with that achieved with a standard treatment such as pemetrexed and cisplatin, coupled with an acceptable safety profile.

KW - Advanced non-small-cell lung cancer

KW - Chemotherapy

KW - Nonsquamous histologic subtype

KW - Pemetrexed

KW - Vinorelbine

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U2 - 10.1016/j.cllc.2014.04.007

DO - 10.1016/j.cllc.2014.04.007

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