Safety and efficacy analysis by histology of weekly nab-paclitaxel in combination with carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer

Mark A. Socinski, I. Okamoto, J. K. Hon, V. Hirsh, S. R. Dakhil, R. D. Page, J. Orsini, N. Yamamoto, H. Zhang, M. F. Renschler

Research output: Contribution to journalArticle

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Abstract

Background: This analysis compared the efficacy and safety outcomes by histology of nab-paclitaxel (nab-P) plus carboplatin (C) versus solvent-based paclitaxel (sb-P) plus C in patients with advanced non-small-cell lung cancer (NSCLC) based on preplanned stratification factors specified in the phase III trial protocol. Patients and methods: Patients with untreated stage III/IV NSCLC received 100 mg/m2 nab-P weekly and C (area under the curve, AUC = 6) every 3 weeks (q3w) or 200 mg/m2 sb-P plus C (AUC = 6) q3w. Primary end point was objective overall response rate (ORR). Results: nab-P/C versus sb-P/C produced a significantly higher ORR (41% versus 24%; response rate ratio [RRR] 1.680; P < 0.001) in patients with squamous cell (SCC) NSCLC. For nab-P/C versus sb-P/C, ORRs were 26% versus 27% (RRR 0.966; P = 0.814) in patients with adenocarcinoma, 33% versus 15% (RRR 2.167; P = 0.323) in patients with large cell carcinoma (LC), and 24% versus 15% (RRR 1.593; P = 0.372) in patients with not otherwise specified histology. Median overall survival for nab-P/C versus sb-P/C in patients with SCC was 10.7 versus 9.5 months (HR 0.890; P = 0.310), and 12.4 versus 10.6 months (HR 1.208; P = 0.721) for patients with LC. nab-P/C produced significantly (P < 0.05) less grade 3/4 neuropathy and arthralgia, whereas sb-P/C produced less thrombocytopenia and anemia. Conclusion(s): First-line nab-P/C demonstrated a favorable risk-benefit profile in patients with NSCLC regardless of histology.

Original languageEnglish
Article numbermdt235
Pages (from-to)2390-2396
Number of pages7
JournalAnnals of Oncology
Volume24
Issue number9
DOIs
Publication statusPublished - Sep 1 2013
Externally publishedYes

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Carboplatin
Non-Small Cell Lung Carcinoma
Histology
Safety
Paclitaxel
Area Under Curve
Therapeutics
Large Cell Carcinoma
130-nm albumin-bound paclitaxel
Arthralgia
Clinical Protocols
Thrombocytopenia
Anemia
Adenocarcinoma
Epithelial Cells
Survival

All Science Journal Classification (ASJC) codes

  • Hematology
  • Oncology

Cite this

Safety and efficacy analysis by histology of weekly nab-paclitaxel in combination with carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer. / Socinski, Mark A.; Okamoto, I.; Hon, J. K.; Hirsh, V.; Dakhil, S. R.; Page, R. D.; Orsini, J.; Yamamoto, N.; Zhang, H.; Renschler, M. F.

In: Annals of Oncology, Vol. 24, No. 9, mdt235, 01.09.2013, p. 2390-2396.

Research output: Contribution to journalArticle

Socinski, Mark A. ; Okamoto, I. ; Hon, J. K. ; Hirsh, V. ; Dakhil, S. R. ; Page, R. D. ; Orsini, J. ; Yamamoto, N. ; Zhang, H. ; Renschler, M. F. / Safety and efficacy analysis by histology of weekly nab-paclitaxel in combination with carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer. In: Annals of Oncology. 2013 ; Vol. 24, No. 9. pp. 2390-2396.
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abstract = "Background: This analysis compared the efficacy and safety outcomes by histology of nab-paclitaxel (nab-P) plus carboplatin (C) versus solvent-based paclitaxel (sb-P) plus C in patients with advanced non-small-cell lung cancer (NSCLC) based on preplanned stratification factors specified in the phase III trial protocol. Patients and methods: Patients with untreated stage III/IV NSCLC received 100 mg/m2 nab-P weekly and C (area under the curve, AUC = 6) every 3 weeks (q3w) or 200 mg/m2 sb-P plus C (AUC = 6) q3w. Primary end point was objective overall response rate (ORR). Results: nab-P/C versus sb-P/C produced a significantly higher ORR (41{\%} versus 24{\%}; response rate ratio [RRR] 1.680; P < 0.001) in patients with squamous cell (SCC) NSCLC. For nab-P/C versus sb-P/C, ORRs were 26{\%} versus 27{\%} (RRR 0.966; P = 0.814) in patients with adenocarcinoma, 33{\%} versus 15{\%} (RRR 2.167; P = 0.323) in patients with large cell carcinoma (LC), and 24{\%} versus 15{\%} (RRR 1.593; P = 0.372) in patients with not otherwise specified histology. Median overall survival for nab-P/C versus sb-P/C in patients with SCC was 10.7 versus 9.5 months (HR 0.890; P = 0.310), and 12.4 versus 10.6 months (HR 1.208; P = 0.721) for patients with LC. nab-P/C produced significantly (P < 0.05) less grade 3/4 neuropathy and arthralgia, whereas sb-P/C produced less thrombocytopenia and anemia. Conclusion(s): First-line nab-P/C demonstrated a favorable risk-benefit profile in patients with NSCLC regardless of histology.",
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T1 - Safety and efficacy analysis by histology of weekly nab-paclitaxel in combination with carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer

AU - Socinski, Mark A.

AU - Okamoto, I.

AU - Hon, J. K.

AU - Hirsh, V.

AU - Dakhil, S. R.

AU - Page, R. D.

AU - Orsini, J.

AU - Yamamoto, N.

AU - Zhang, H.

AU - Renschler, M. F.

PY - 2013/9/1

Y1 - 2013/9/1

N2 - Background: This analysis compared the efficacy and safety outcomes by histology of nab-paclitaxel (nab-P) plus carboplatin (C) versus solvent-based paclitaxel (sb-P) plus C in patients with advanced non-small-cell lung cancer (NSCLC) based on preplanned stratification factors specified in the phase III trial protocol. Patients and methods: Patients with untreated stage III/IV NSCLC received 100 mg/m2 nab-P weekly and C (area under the curve, AUC = 6) every 3 weeks (q3w) or 200 mg/m2 sb-P plus C (AUC = 6) q3w. Primary end point was objective overall response rate (ORR). Results: nab-P/C versus sb-P/C produced a significantly higher ORR (41% versus 24%; response rate ratio [RRR] 1.680; P < 0.001) in patients with squamous cell (SCC) NSCLC. For nab-P/C versus sb-P/C, ORRs were 26% versus 27% (RRR 0.966; P = 0.814) in patients with adenocarcinoma, 33% versus 15% (RRR 2.167; P = 0.323) in patients with large cell carcinoma (LC), and 24% versus 15% (RRR 1.593; P = 0.372) in patients with not otherwise specified histology. Median overall survival for nab-P/C versus sb-P/C in patients with SCC was 10.7 versus 9.5 months (HR 0.890; P = 0.310), and 12.4 versus 10.6 months (HR 1.208; P = 0.721) for patients with LC. nab-P/C produced significantly (P < 0.05) less grade 3/4 neuropathy and arthralgia, whereas sb-P/C produced less thrombocytopenia and anemia. Conclusion(s): First-line nab-P/C demonstrated a favorable risk-benefit profile in patients with NSCLC regardless of histology.

AB - Background: This analysis compared the efficacy and safety outcomes by histology of nab-paclitaxel (nab-P) plus carboplatin (C) versus solvent-based paclitaxel (sb-P) plus C in patients with advanced non-small-cell lung cancer (NSCLC) based on preplanned stratification factors specified in the phase III trial protocol. Patients and methods: Patients with untreated stage III/IV NSCLC received 100 mg/m2 nab-P weekly and C (area under the curve, AUC = 6) every 3 weeks (q3w) or 200 mg/m2 sb-P plus C (AUC = 6) q3w. Primary end point was objective overall response rate (ORR). Results: nab-P/C versus sb-P/C produced a significantly higher ORR (41% versus 24%; response rate ratio [RRR] 1.680; P < 0.001) in patients with squamous cell (SCC) NSCLC. For nab-P/C versus sb-P/C, ORRs were 26% versus 27% (RRR 0.966; P = 0.814) in patients with adenocarcinoma, 33% versus 15% (RRR 2.167; P = 0.323) in patients with large cell carcinoma (LC), and 24% versus 15% (RRR 1.593; P = 0.372) in patients with not otherwise specified histology. Median overall survival for nab-P/C versus sb-P/C in patients with SCC was 10.7 versus 9.5 months (HR 0.890; P = 0.310), and 12.4 versus 10.6 months (HR 1.208; P = 0.721) for patients with LC. nab-P/C produced significantly (P < 0.05) less grade 3/4 neuropathy and arthralgia, whereas sb-P/C produced less thrombocytopenia and anemia. Conclusion(s): First-line nab-P/C demonstrated a favorable risk-benefit profile in patients with NSCLC regardless of histology.

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