Phase 2 study of pemetrexed plus carboplatin, or pemetrexed plus cisplatin with concurrent radiation therapy followed by pemetrexed consolidation in patients with favorable-prognosis inoperable stage IIIA/B non-small-cell lung cancer

Hak Choy, Lee Schwartzberg, Shaker R. Dakhil, Edward B. Garon, David E. Gerber, Janak K. Choksi, Ramaswamy Govindan, Guangbin Peng, Andrew Koustenis, Joseph Treat, Coleman Obasaju

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Abstract

Introduction: There is no consensus chemotherapy regimen with concurrent radiotherapy (RT) for inoperable stage IIIA/B non-small-cell lung cancer. This trial evaluated pemetrexed with carboplatin (PCb) or cisplatin (PC) with concurrent RT followed by consolidation pemetrexed. Methods: In this open-label, noncomparative phase II trial, patients with inoperable stage IIIA/B non-small-cell lung cancer (initially all histologies, later restricted to nonsquamous) were randomized (1:1) to PCb or PC with concurrent RT (64-68 Gy over days 1-45). Consolidation pemetrexed monotherapy was administered every 21 days for three cycles. Primary endpoint was 2-year overall survival (OS) rate. Results: From June 2007 to November 2009, 98 patients were enrolled (PCb: 46; PC: 52). The 2-year OS rate was PCb: 45.4% (95% confidence interval [CI], 29.5-60.0%); PC: 58.4% (95% CI, 42.6-71.3%), and in nonsquamous patients was PCb: 48.0% (95% CI, 29.0-64.8%); PC: 55.8% (95% CI, 38.0-70.3%). Median time to disease progression was PCb: 8.8 months (95% CI, 6.0-12.6 months); PC: 13.1 months (95% CI, 8.3-not evaluable [NE]). Median OS (months) was PCb: 18.7 (95% CI, 12.9-NE); PC: 27.0 (95% CI, 23.2-NE). The objective response rates (ORRs) were PCb: 52.2%; PC: 46.2%. Grade 4 treatment-related toxicities (% PCb/% PC) were: anemia, 0/1.9; neutropenia, 6.5/3.8; thrombocytopenia, 4.3/1.9; and esophagitis, 0/1.9. Most patients completed scheduled chemotherapy and RT during induction and consolidation phases. No drug-related deaths were reported during chemoradiotherapy. Conclusions: Because of study design, efficacy comparisons cannot be made. However, both combinations with concurrent RT were active and well tolerated.

Original languageEnglish (US)
Pages (from-to)1308-1316
Number of pages9
JournalJournal of Thoracic Oncology
Volume8
Issue number10
DOIs
StatePublished - Jan 1 2013

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Pemetrexed
Carboplatin
Non-Small Cell Lung Carcinoma
Cisplatin
Radiotherapy
Confidence Intervals
Survival Rate
Drug Therapy
Esophagitis
Chemoradiotherapy
Neutropenia

All Science Journal Classification (ASJC) codes

  • Oncology
  • Pulmonary and Respiratory Medicine

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Phase 2 study of pemetrexed plus carboplatin, or pemetrexed plus cisplatin with concurrent radiation therapy followed by pemetrexed consolidation in patients with favorable-prognosis inoperable stage IIIA/B non-small-cell lung cancer. / Choy, Hak; Schwartzberg, Lee; Dakhil, Shaker R.; Garon, Edward B.; Gerber, David E.; Choksi, Janak K.; Govindan, Ramaswamy; Peng, Guangbin; Koustenis, Andrew; Treat, Joseph; Obasaju, Coleman.

In: Journal of Thoracic Oncology, Vol. 8, No. 10, 01.01.2013, p. 1308-1316.

Research output: Contribution to journalArticle

Choy, Hak ; Schwartzberg, Lee ; Dakhil, Shaker R. ; Garon, Edward B. ; Gerber, David E. ; Choksi, Janak K. ; Govindan, Ramaswamy ; Peng, Guangbin ; Koustenis, Andrew ; Treat, Joseph ; Obasaju, Coleman. / Phase 2 study of pemetrexed plus carboplatin, or pemetrexed plus cisplatin with concurrent radiation therapy followed by pemetrexed consolidation in patients with favorable-prognosis inoperable stage IIIA/B non-small-cell lung cancer. In: Journal of Thoracic Oncology. 2013 ; Vol. 8, No. 10. pp. 1308-1316.
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title = "Phase 2 study of pemetrexed plus carboplatin, or pemetrexed plus cisplatin with concurrent radiation therapy followed by pemetrexed consolidation in patients with favorable-prognosis inoperable stage IIIA/B non-small-cell lung cancer",
abstract = "Introduction: There is no consensus chemotherapy regimen with concurrent radiotherapy (RT) for inoperable stage IIIA/B non-small-cell lung cancer. This trial evaluated pemetrexed with carboplatin (PCb) or cisplatin (PC) with concurrent RT followed by consolidation pemetrexed. Methods: In this open-label, noncomparative phase II trial, patients with inoperable stage IIIA/B non-small-cell lung cancer (initially all histologies, later restricted to nonsquamous) were randomized (1:1) to PCb or PC with concurrent RT (64-68 Gy over days 1-45). Consolidation pemetrexed monotherapy was administered every 21 days for three cycles. Primary endpoint was 2-year overall survival (OS) rate. Results: From June 2007 to November 2009, 98 patients were enrolled (PCb: 46; PC: 52). The 2-year OS rate was PCb: 45.4{\%} (95{\%} confidence interval [CI], 29.5-60.0{\%}); PC: 58.4{\%} (95{\%} CI, 42.6-71.3{\%}), and in nonsquamous patients was PCb: 48.0{\%} (95{\%} CI, 29.0-64.8{\%}); PC: 55.8{\%} (95{\%} CI, 38.0-70.3{\%}). Median time to disease progression was PCb: 8.8 months (95{\%} CI, 6.0-12.6 months); PC: 13.1 months (95{\%} CI, 8.3-not evaluable [NE]). Median OS (months) was PCb: 18.7 (95{\%} CI, 12.9-NE); PC: 27.0 (95{\%} CI, 23.2-NE). The objective response rates (ORRs) were PCb: 52.2{\%}; PC: 46.2{\%}. Grade 4 treatment-related toxicities ({\%} PCb/{\%} PC) were: anemia, 0/1.9; neutropenia, 6.5/3.8; thrombocytopenia, 4.3/1.9; and esophagitis, 0/1.9. Most patients completed scheduled chemotherapy and RT during induction and consolidation phases. No drug-related deaths were reported during chemoradiotherapy. Conclusions: Because of study design, efficacy comparisons cannot be made. However, both combinations with concurrent RT were active and well tolerated.",
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T1 - Phase 2 study of pemetrexed plus carboplatin, or pemetrexed plus cisplatin with concurrent radiation therapy followed by pemetrexed consolidation in patients with favorable-prognosis inoperable stage IIIA/B non-small-cell lung cancer

AU - Choy, Hak

AU - Schwartzberg, Lee

AU - Dakhil, Shaker R.

AU - Garon, Edward B.

AU - Gerber, David E.

AU - Choksi, Janak K.

AU - Govindan, Ramaswamy

AU - Peng, Guangbin

AU - Koustenis, Andrew

AU - Treat, Joseph

AU - Obasaju, Coleman

PY - 2013/1/1

Y1 - 2013/1/1

N2 - Introduction: There is no consensus chemotherapy regimen with concurrent radiotherapy (RT) for inoperable stage IIIA/B non-small-cell lung cancer. This trial evaluated pemetrexed with carboplatin (PCb) or cisplatin (PC) with concurrent RT followed by consolidation pemetrexed. Methods: In this open-label, noncomparative phase II trial, patients with inoperable stage IIIA/B non-small-cell lung cancer (initially all histologies, later restricted to nonsquamous) were randomized (1:1) to PCb or PC with concurrent RT (64-68 Gy over days 1-45). Consolidation pemetrexed monotherapy was administered every 21 days for three cycles. Primary endpoint was 2-year overall survival (OS) rate. Results: From June 2007 to November 2009, 98 patients were enrolled (PCb: 46; PC: 52). The 2-year OS rate was PCb: 45.4% (95% confidence interval [CI], 29.5-60.0%); PC: 58.4% (95% CI, 42.6-71.3%), and in nonsquamous patients was PCb: 48.0% (95% CI, 29.0-64.8%); PC: 55.8% (95% CI, 38.0-70.3%). Median time to disease progression was PCb: 8.8 months (95% CI, 6.0-12.6 months); PC: 13.1 months (95% CI, 8.3-not evaluable [NE]). Median OS (months) was PCb: 18.7 (95% CI, 12.9-NE); PC: 27.0 (95% CI, 23.2-NE). The objective response rates (ORRs) were PCb: 52.2%; PC: 46.2%. Grade 4 treatment-related toxicities (% PCb/% PC) were: anemia, 0/1.9; neutropenia, 6.5/3.8; thrombocytopenia, 4.3/1.9; and esophagitis, 0/1.9. Most patients completed scheduled chemotherapy and RT during induction and consolidation phases. No drug-related deaths were reported during chemoradiotherapy. Conclusions: Because of study design, efficacy comparisons cannot be made. However, both combinations with concurrent RT were active and well tolerated.

AB - Introduction: There is no consensus chemotherapy regimen with concurrent radiotherapy (RT) for inoperable stage IIIA/B non-small-cell lung cancer. This trial evaluated pemetrexed with carboplatin (PCb) or cisplatin (PC) with concurrent RT followed by consolidation pemetrexed. Methods: In this open-label, noncomparative phase II trial, patients with inoperable stage IIIA/B non-small-cell lung cancer (initially all histologies, later restricted to nonsquamous) were randomized (1:1) to PCb or PC with concurrent RT (64-68 Gy over days 1-45). Consolidation pemetrexed monotherapy was administered every 21 days for three cycles. Primary endpoint was 2-year overall survival (OS) rate. Results: From June 2007 to November 2009, 98 patients were enrolled (PCb: 46; PC: 52). The 2-year OS rate was PCb: 45.4% (95% confidence interval [CI], 29.5-60.0%); PC: 58.4% (95% CI, 42.6-71.3%), and in nonsquamous patients was PCb: 48.0% (95% CI, 29.0-64.8%); PC: 55.8% (95% CI, 38.0-70.3%). Median time to disease progression was PCb: 8.8 months (95% CI, 6.0-12.6 months); PC: 13.1 months (95% CI, 8.3-not evaluable [NE]). Median OS (months) was PCb: 18.7 (95% CI, 12.9-NE); PC: 27.0 (95% CI, 23.2-NE). The objective response rates (ORRs) were PCb: 52.2%; PC: 46.2%. Grade 4 treatment-related toxicities (% PCb/% PC) were: anemia, 0/1.9; neutropenia, 6.5/3.8; thrombocytopenia, 4.3/1.9; and esophagitis, 0/1.9. Most patients completed scheduled chemotherapy and RT during induction and consolidation phases. No drug-related deaths were reported during chemoradiotherapy. Conclusions: Because of study design, efficacy comparisons cannot be made. However, both combinations with concurrent RT were active and well tolerated.

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