Phase II multicenter trial with carboplatin and gemcitabine induction chemotherapy followed by radiotherapy concomitantly with low-dose paclitaxel and gemcitabine for stage IIIA and IIIB non-small cell lung cancer

Vera Hirsh, Denis Soulieres, Marie Duclos, Sergio Faria, Pierre Del Vecchio, Linda Ofiara, Jean Pierre Ayoub, Danielle Charpentier, James Gruber, Lorraine Portelance, Luis Souhami

Research output: Contribution to journalArticle

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Abstract

INTRODUCTION: The optimal combination of concomitant radiotherapy (RT) and chemotherapy in stage III unresectable non-small cell lung cancer (NSCLC) remains unclear. The role of induction chemotherapy with carboplatin/gemcitabine regimen has not been established in stage III NSCLC. METHODS: Forty-two stage III NSCLC patients, 41 assessable, with a median age of 60 years and good performance status, entered this trial between January 2003 and November 2004. They received carboplatin area under the curve 5 on day 1 and gemcitabine 1000 mg/m on days 1 + 8 every 3 weeks for two cycles, followed on day 50 by RT 60 Gy, concomitantly with paclitaxel 50 mg/m and gemcitabine 100 mg/m on days 1 + 8 every 3 weeks for two cycles. RESULTS: After induction, the partial response (PR) was 73.1% and stable disease was 24.4%. Disease progressed in one patient. After RT and paclitaxel/gemcitabine, 22% achieved a complete response and 73% a PR, and 5% had disease progression. The median survival was 25 months, the 1-year survival rate was 73.2%, and the 2-year survival rate was 50.5%. During concomitant RT and chemotherapy, grade 3 neutropenia, thrombocytopenia, and anemia occurred in eight, three, and three patients, respectively, and grade 4 neutropenia and thrombocytopenia in one patient each. One patient developed an esophageal fistula and died shortly after, which was considered a grade 5 toxicity; one patient developed grade 4 interstitial pneumonitis, and three patients developed grade 3 esophagitis. CONCLUSION: This regimen appears to be effective and was well tolerated. Further studies using this approach are warranted in patients with stage III NSCLC.

Original languageEnglish
Pages (from-to)927-932
Number of pages6
JournalJournal of Thoracic Oncology
Volume2
Issue number10
DOIs
StatePublished - Oct 1 2007
Externally publishedYes

Fingerprint

gemcitabine
Induction Chemotherapy
Carboplatin
Paclitaxel
Non-Small Cell Lung Carcinoma
Multicenter Studies
Radiotherapy
Neutropenia
Survival Rate
Esophageal Fistula
Drug Therapy
Esophagitis
Interstitial Lung Diseases
Area Under Curve
Disease Progression
Anemia

Keywords

  • Carboplatin/gemcitabine induction
  • Concomitant radiochemotherapy
  • Lung cancer
  • Neoadjuvant chemotherapy
  • Stage IIIA/B non-small cell lung cancer

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine

Cite this

Phase II multicenter trial with carboplatin and gemcitabine induction chemotherapy followed by radiotherapy concomitantly with low-dose paclitaxel and gemcitabine for stage IIIA and IIIB non-small cell lung cancer. / Hirsh, Vera; Soulieres, Denis; Duclos, Marie; Faria, Sergio; Del Vecchio, Pierre; Ofiara, Linda; Ayoub, Jean Pierre; Charpentier, Danielle; Gruber, James; Portelance, Lorraine; Souhami, Luis.

In: Journal of Thoracic Oncology, Vol. 2, No. 10, 01.10.2007, p. 927-932.

Research output: Contribution to journalArticle

Hirsh, Vera ; Soulieres, Denis ; Duclos, Marie ; Faria, Sergio ; Del Vecchio, Pierre ; Ofiara, Linda ; Ayoub, Jean Pierre ; Charpentier, Danielle ; Gruber, James ; Portelance, Lorraine ; Souhami, Luis. / Phase II multicenter trial with carboplatin and gemcitabine induction chemotherapy followed by radiotherapy concomitantly with low-dose paclitaxel and gemcitabine for stage IIIA and IIIB non-small cell lung cancer. In: Journal of Thoracic Oncology. 2007 ; Vol. 2, No. 10. pp. 927-932.
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abstract = "INTRODUCTION: The optimal combination of concomitant radiotherapy (RT) and chemotherapy in stage III unresectable non-small cell lung cancer (NSCLC) remains unclear. The role of induction chemotherapy with carboplatin/gemcitabine regimen has not been established in stage III NSCLC. METHODS: Forty-two stage III NSCLC patients, 41 assessable, with a median age of 60 years and good performance status, entered this trial between January 2003 and November 2004. They received carboplatin area under the curve 5 on day 1 and gemcitabine 1000 mg/m on days 1 + 8 every 3 weeks for two cycles, followed on day 50 by RT 60 Gy, concomitantly with paclitaxel 50 mg/m and gemcitabine 100 mg/m on days 1 + 8 every 3 weeks for two cycles. RESULTS: After induction, the partial response (PR) was 73.1{\%} and stable disease was 24.4{\%}. Disease progressed in one patient. After RT and paclitaxel/gemcitabine, 22{\%} achieved a complete response and 73{\%} a PR, and 5{\%} had disease progression. The median survival was 25 months, the 1-year survival rate was 73.2{\%}, and the 2-year survival rate was 50.5{\%}. During concomitant RT and chemotherapy, grade 3 neutropenia, thrombocytopenia, and anemia occurred in eight, three, and three patients, respectively, and grade 4 neutropenia and thrombocytopenia in one patient each. One patient developed an esophageal fistula and died shortly after, which was considered a grade 5 toxicity; one patient developed grade 4 interstitial pneumonitis, and three patients developed grade 3 esophagitis. CONCLUSION: This regimen appears to be effective and was well tolerated. Further studies using this approach are warranted in patients with stage III NSCLC.",
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T1 - Phase II multicenter trial with carboplatin and gemcitabine induction chemotherapy followed by radiotherapy concomitantly with low-dose paclitaxel and gemcitabine for stage IIIA and IIIB non-small cell lung cancer

AU - Hirsh, Vera

AU - Soulieres, Denis

AU - Duclos, Marie

AU - Faria, Sergio

AU - Del Vecchio, Pierre

AU - Ofiara, Linda

AU - Ayoub, Jean Pierre

AU - Charpentier, Danielle

AU - Gruber, James

AU - Portelance, Lorraine

AU - Souhami, Luis

PY - 2007/10/1

Y1 - 2007/10/1

N2 - INTRODUCTION: The optimal combination of concomitant radiotherapy (RT) and chemotherapy in stage III unresectable non-small cell lung cancer (NSCLC) remains unclear. The role of induction chemotherapy with carboplatin/gemcitabine regimen has not been established in stage III NSCLC. METHODS: Forty-two stage III NSCLC patients, 41 assessable, with a median age of 60 years and good performance status, entered this trial between January 2003 and November 2004. They received carboplatin area under the curve 5 on day 1 and gemcitabine 1000 mg/m on days 1 + 8 every 3 weeks for two cycles, followed on day 50 by RT 60 Gy, concomitantly with paclitaxel 50 mg/m and gemcitabine 100 mg/m on days 1 + 8 every 3 weeks for two cycles. RESULTS: After induction, the partial response (PR) was 73.1% and stable disease was 24.4%. Disease progressed in one patient. After RT and paclitaxel/gemcitabine, 22% achieved a complete response and 73% a PR, and 5% had disease progression. The median survival was 25 months, the 1-year survival rate was 73.2%, and the 2-year survival rate was 50.5%. During concomitant RT and chemotherapy, grade 3 neutropenia, thrombocytopenia, and anemia occurred in eight, three, and three patients, respectively, and grade 4 neutropenia and thrombocytopenia in one patient each. One patient developed an esophageal fistula and died shortly after, which was considered a grade 5 toxicity; one patient developed grade 4 interstitial pneumonitis, and three patients developed grade 3 esophagitis. CONCLUSION: This regimen appears to be effective and was well tolerated. Further studies using this approach are warranted in patients with stage III NSCLC.

AB - INTRODUCTION: The optimal combination of concomitant radiotherapy (RT) and chemotherapy in stage III unresectable non-small cell lung cancer (NSCLC) remains unclear. The role of induction chemotherapy with carboplatin/gemcitabine regimen has not been established in stage III NSCLC. METHODS: Forty-two stage III NSCLC patients, 41 assessable, with a median age of 60 years and good performance status, entered this trial between January 2003 and November 2004. They received carboplatin area under the curve 5 on day 1 and gemcitabine 1000 mg/m on days 1 + 8 every 3 weeks for two cycles, followed on day 50 by RT 60 Gy, concomitantly with paclitaxel 50 mg/m and gemcitabine 100 mg/m on days 1 + 8 every 3 weeks for two cycles. RESULTS: After induction, the partial response (PR) was 73.1% and stable disease was 24.4%. Disease progressed in one patient. After RT and paclitaxel/gemcitabine, 22% achieved a complete response and 73% a PR, and 5% had disease progression. The median survival was 25 months, the 1-year survival rate was 73.2%, and the 2-year survival rate was 50.5%. During concomitant RT and chemotherapy, grade 3 neutropenia, thrombocytopenia, and anemia occurred in eight, three, and three patients, respectively, and grade 4 neutropenia and thrombocytopenia in one patient each. One patient developed an esophageal fistula and died shortly after, which was considered a grade 5 toxicity; one patient developed grade 4 interstitial pneumonitis, and three patients developed grade 3 esophagitis. CONCLUSION: This regimen appears to be effective and was well tolerated. Further studies using this approach are warranted in patients with stage III NSCLC.

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KW - Concomitant radiochemotherapy

KW - Lung cancer

KW - Neoadjuvant chemotherapy

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