Adding gemcitabine to paclitaxel/carboplatin combination increases survival in advanced non-small-cell lung cancer

Results of a phase II-III study

Adriano Paccagnella, Francesco Oniga, Alessandra Bearz, Adolfo Favaretto, Maurizia Clerici, Fausto Barbieri, Alberto Riccardi, Antonio Chella, Umberto Tirelli, Giovanni Ceresoli, Salvatore Tumolo, Ruggero Ridolfi, Rita Biason, Maria Ornella Nicoletto, Paolo Belloni, Fabrizio Veglia, Maria Grazia Ghi

Research output: Contribution to journalArticle

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Abstract

Purpose: Paclitaxel/carboplatin (PC) is one of the reference combinations in the treatment of non-small-cell lung cancer (NSCLC). No triplet novel agent combination has until now shown superiority over a two-drug combination for advanced NSCLC. We therefore conducted a clinical trial to test if paclitaxel/carboplatin/gemcitabine (PCG) increases overall survival (OS) and response rate (RR) over PC. Methods: Stage IIIB patients not suitable for radical radiation treatment and stage IV chemotherapy-naive patients with measurable disease and performance status of 0 to 2 were randomly assigned to PC arm (paclitaxel 200 mg/m2 and carboplatin area under the concentration-time curve 6 day 1/q21 days) or the PCG arm (paclitaxel 200 mg/m2 and carboplatin area under the concentration-time curve 6 day 1, and gemcitabine 1,000 mg/m2 days 1 and 8 every 21 days). Results: A total of 324 patients were randomly assigned to the two arms. The RR for PC arm and PCG arm were 20.2% and 46% (P <.0001). The median time to the progression was 5.1 months in the PC group and 7.6 months in the PCG group (P = .012; hazard ratio [HR] 1.34; 95% CI: 1.06 to 1.72). Median OS was 8.3 months and 10.8 months (P = .032; HR 1.309; 95% CI: 1.03 to 1.67) in favor of the PCG arm. One-year survival was 34% (PC arm) and 45% (PCG arm; P = .032). Only hematologic toxicity (neutropenia, thrombocytopenia, and anemia) was significantly increased in the PCG arm and the experimental arm required more platelet and red blood cell transfusions, and more granulocyte colony-stimulating factor usage. No toxic/early deaths were observed. Conclusion: The PCG regimen offers a significant survival advantage over PC in advanced NSCLC, making PCG a treatment option for advanced NSCLC patients.

Original languageEnglish
Pages (from-to)681-687
Number of pages7
JournalJournal of Clinical Oncology
Volume24
Issue number4
DOIs
Publication statusPublished - Feb 1 2006

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gemcitabine
Carboplatin
Paclitaxel
Non-Small Cell Lung Carcinoma
Survival

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Adding gemcitabine to paclitaxel/carboplatin combination increases survival in advanced non-small-cell lung cancer : Results of a phase II-III study. / Paccagnella, Adriano; Oniga, Francesco; Bearz, Alessandra; Favaretto, Adolfo; Clerici, Maurizia; Barbieri, Fausto; Riccardi, Alberto; Chella, Antonio; Tirelli, Umberto; Ceresoli, Giovanni; Tumolo, Salvatore; Ridolfi, Ruggero; Biason, Rita; Nicoletto, Maria Ornella; Belloni, Paolo; Veglia, Fabrizio; Ghi, Maria Grazia.

In: Journal of Clinical Oncology, Vol. 24, No. 4, 01.02.2006, p. 681-687.

Research output: Contribution to journalArticle

Paccagnella, A, Oniga, F, Bearz, A, Favaretto, A, Clerici, M, Barbieri, F, Riccardi, A, Chella, A, Tirelli, U, Ceresoli, G, Tumolo, S, Ridolfi, R, Biason, R, Nicoletto, MO, Belloni, P, Veglia, F & Ghi, MG 2006, 'Adding gemcitabine to paclitaxel/carboplatin combination increases survival in advanced non-small-cell lung cancer: Results of a phase II-III study', Journal of Clinical Oncology, vol. 24, no. 4, pp. 681-687. https://doi.org/10.1200/JCO.2005.03.2722
Paccagnella, Adriano ; Oniga, Francesco ; Bearz, Alessandra ; Favaretto, Adolfo ; Clerici, Maurizia ; Barbieri, Fausto ; Riccardi, Alberto ; Chella, Antonio ; Tirelli, Umberto ; Ceresoli, Giovanni ; Tumolo, Salvatore ; Ridolfi, Ruggero ; Biason, Rita ; Nicoletto, Maria Ornella ; Belloni, Paolo ; Veglia, Fabrizio ; Ghi, Maria Grazia. / Adding gemcitabine to paclitaxel/carboplatin combination increases survival in advanced non-small-cell lung cancer : Results of a phase II-III study. In: Journal of Clinical Oncology. 2006 ; Vol. 24, No. 4. pp. 681-687.
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T2 - Results of a phase II-III study

AU - Paccagnella, Adriano

AU - Oniga, Francesco

AU - Bearz, Alessandra

AU - Favaretto, Adolfo

AU - Clerici, Maurizia

AU - Barbieri, Fausto

AU - Riccardi, Alberto

AU - Chella, Antonio

AU - Tirelli, Umberto

AU - Ceresoli, Giovanni

AU - Tumolo, Salvatore

AU - Ridolfi, Ruggero

AU - Biason, Rita

AU - Nicoletto, Maria Ornella

AU - Belloni, Paolo

AU - Veglia, Fabrizio

AU - Ghi, Maria Grazia

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N2 - Purpose: Paclitaxel/carboplatin (PC) is one of the reference combinations in the treatment of non-small-cell lung cancer (NSCLC). No triplet novel agent combination has until now shown superiority over a two-drug combination for advanced NSCLC. We therefore conducted a clinical trial to test if paclitaxel/carboplatin/gemcitabine (PCG) increases overall survival (OS) and response rate (RR) over PC. Methods: Stage IIIB patients not suitable for radical radiation treatment and stage IV chemotherapy-naive patients with measurable disease and performance status of 0 to 2 were randomly assigned to PC arm (paclitaxel 200 mg/m2 and carboplatin area under the concentration-time curve 6 day 1/q21 days) or the PCG arm (paclitaxel 200 mg/m2 and carboplatin area under the concentration-time curve 6 day 1, and gemcitabine 1,000 mg/m2 days 1 and 8 every 21 days). Results: A total of 324 patients were randomly assigned to the two arms. The RR for PC arm and PCG arm were 20.2% and 46% (P <.0001). The median time to the progression was 5.1 months in the PC group and 7.6 months in the PCG group (P = .012; hazard ratio [HR] 1.34; 95% CI: 1.06 to 1.72). Median OS was 8.3 months and 10.8 months (P = .032; HR 1.309; 95% CI: 1.03 to 1.67) in favor of the PCG arm. One-year survival was 34% (PC arm) and 45% (PCG arm; P = .032). Only hematologic toxicity (neutropenia, thrombocytopenia, and anemia) was significantly increased in the PCG arm and the experimental arm required more platelet and red blood cell transfusions, and more granulocyte colony-stimulating factor usage. No toxic/early deaths were observed. Conclusion: The PCG regimen offers a significant survival advantage over PC in advanced NSCLC, making PCG a treatment option for advanced NSCLC patients.

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