Neoadjuvant chemotherapy with gemcitabine-containing regimens in patients with early-stage non-small cell lung cancer

Frank C. Detterbeck, Mark A. Socinski, Richard J. Gralla, Martin J. Edelman, Thierry M. Jahan, David M. Loesch, Steven A. Limentani, Ramaswamy Govindan, M. B. Zaman, Zhishen Ye, Matthew J. Monberg, Coleman K. Obasaju

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

BACKGROUND: Surgical resection alone remains suboptimal for patients with early-stage (I or II) non-small cell lung cancer. Two similar randomized phase II trials were conducted to define an active preoperative regimen in this disease state. METHODS: In the first study, patients were randomized to receive gemcitabine 1000 mg/m on days 1 and 8 plus cisplatin 80 mg/m on day 1 (GC) or gemcitabine 1000 mg/m on days 1 and 8 plus carboplatin area under the curve 5.5 on day 1 (GCb). In the second trial, patients received the same regimen of GCb or gemcitabine 1000 mg/m on days 1 and 8 plus paclitaxel 200 mg/m on day 1 (GP). Cycles were repeated every 21 days for three cycles. The primary end point was pathologic complete response (pCR) rate. RESULTS: Eighty-seven eligible patients were randomized (GC n = 12, GP n = 35, and GCb n = 40), and 71 (82%) underwent surgery after chemotherapy. The confirmed pCR rate was 2.3% (2 of 87, 95% confidence interval 0.3-8.1). Clinical response rate was 28.7%, complete resection rate was 91.5% (65 of 71 patients), and perioperative mortality rate was 2.8%. As of October 2006, median survival for all patients was 45 months (65.5% censored), with 87.2% alive at 1 year and 69.8% alive at 2 years. DISCUSSION: Neoadjuvant chemotherapy with gemcitabine was feasible and well tolerated, and outcomes were similar to other reports of this treatment strategy. However, no regimen achieved the predefined pCR rate that would be sufficient to warrant further evaluation in the phase III setting. This trial design provides an efficient way of providing a rationale for choosing or rejecting regimens of potential value.

Original languageEnglish (US)
Pages (from-to)37-45
Number of pages9
JournalJournal of Thoracic Oncology
Volume3
Issue number1
DOIs
StatePublished - Jan 2008
Externally publishedYes

Fingerprint

gemcitabine
Non-Small Cell Lung Carcinoma
Drug Therapy
Carboplatin
Paclitaxel
Cisplatin
Area Under Curve
Confidence Intervals

Keywords

  • Early stage
  • Gemcitabine
  • GINEST
  • Multimodality
  • NSCLC
  • Resectability

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine

Cite this

Detterbeck, F. C., Socinski, M. A., Gralla, R. J., Edelman, M. J., Jahan, T. M., Loesch, D. M., ... Obasaju, C. K. (2008). Neoadjuvant chemotherapy with gemcitabine-containing regimens in patients with early-stage non-small cell lung cancer. Journal of Thoracic Oncology, 3(1), 37-45. https://doi.org/10.1097/JTO.0b013e31815e5d9a

Neoadjuvant chemotherapy with gemcitabine-containing regimens in patients with early-stage non-small cell lung cancer. / Detterbeck, Frank C.; Socinski, Mark A.; Gralla, Richard J.; Edelman, Martin J.; Jahan, Thierry M.; Loesch, David M.; Limentani, Steven A.; Govindan, Ramaswamy; Zaman, M. B.; Ye, Zhishen; Monberg, Matthew J.; Obasaju, Coleman K.

In: Journal of Thoracic Oncology, Vol. 3, No. 1, 01.2008, p. 37-45.

Research output: Contribution to journalArticle

Detterbeck, FC, Socinski, MA, Gralla, RJ, Edelman, MJ, Jahan, TM, Loesch, DM, Limentani, SA, Govindan, R, Zaman, MB, Ye, Z, Monberg, MJ & Obasaju, CK 2008, 'Neoadjuvant chemotherapy with gemcitabine-containing regimens in patients with early-stage non-small cell lung cancer', Journal of Thoracic Oncology, vol. 3, no. 1, pp. 37-45. https://doi.org/10.1097/JTO.0b013e31815e5d9a
Detterbeck, Frank C. ; Socinski, Mark A. ; Gralla, Richard J. ; Edelman, Martin J. ; Jahan, Thierry M. ; Loesch, David M. ; Limentani, Steven A. ; Govindan, Ramaswamy ; Zaman, M. B. ; Ye, Zhishen ; Monberg, Matthew J. ; Obasaju, Coleman K. / Neoadjuvant chemotherapy with gemcitabine-containing regimens in patients with early-stage non-small cell lung cancer. In: Journal of Thoracic Oncology. 2008 ; Vol. 3, No. 1. pp. 37-45.
@article{752e82c7ee7b47a69a3752f3f3e97784,
title = "Neoadjuvant chemotherapy with gemcitabine-containing regimens in patients with early-stage non-small cell lung cancer",
abstract = "BACKGROUND: Surgical resection alone remains suboptimal for patients with early-stage (I or II) non-small cell lung cancer. Two similar randomized phase II trials were conducted to define an active preoperative regimen in this disease state. METHODS: In the first study, patients were randomized to receive gemcitabine 1000 mg/m on days 1 and 8 plus cisplatin 80 mg/m on day 1 (GC) or gemcitabine 1000 mg/m on days 1 and 8 plus carboplatin area under the curve 5.5 on day 1 (GCb). In the second trial, patients received the same regimen of GCb or gemcitabine 1000 mg/m on days 1 and 8 plus paclitaxel 200 mg/m on day 1 (GP). Cycles were repeated every 21 days for three cycles. The primary end point was pathologic complete response (pCR) rate. RESULTS: Eighty-seven eligible patients were randomized (GC n = 12, GP n = 35, and GCb n = 40), and 71 (82{\%}) underwent surgery after chemotherapy. The confirmed pCR rate was 2.3{\%} (2 of 87, 95{\%} confidence interval 0.3-8.1). Clinical response rate was 28.7{\%}, complete resection rate was 91.5{\%} (65 of 71 patients), and perioperative mortality rate was 2.8{\%}. As of October 2006, median survival for all patients was 45 months (65.5{\%} censored), with 87.2{\%} alive at 1 year and 69.8{\%} alive at 2 years. DISCUSSION: Neoadjuvant chemotherapy with gemcitabine was feasible and well tolerated, and outcomes were similar to other reports of this treatment strategy. However, no regimen achieved the predefined pCR rate that would be sufficient to warrant further evaluation in the phase III setting. This trial design provides an efficient way of providing a rationale for choosing or rejecting regimens of potential value.",
keywords = "Early stage, Gemcitabine, GINEST, Multimodality, NSCLC, Resectability",
author = "Detterbeck, {Frank C.} and Socinski, {Mark A.} and Gralla, {Richard J.} and Edelman, {Martin J.} and Jahan, {Thierry M.} and Loesch, {David M.} and Limentani, {Steven A.} and Ramaswamy Govindan and Zaman, {M. B.} and Zhishen Ye and Monberg, {Matthew J.} and Obasaju, {Coleman K.}",
year = "2008",
month = "1",
doi = "10.1097/JTO.0b013e31815e5d9a",
language = "English (US)",
volume = "3",
pages = "37--45",
journal = "Journal of Thoracic Oncology",
issn = "1556-0864",
publisher = "International Association for the Study of Lung Cancer",
number = "1",

}

TY - JOUR

T1 - Neoadjuvant chemotherapy with gemcitabine-containing regimens in patients with early-stage non-small cell lung cancer

AU - Detterbeck, Frank C.

AU - Socinski, Mark A.

AU - Gralla, Richard J.

AU - Edelman, Martin J.

AU - Jahan, Thierry M.

AU - Loesch, David M.

AU - Limentani, Steven A.

AU - Govindan, Ramaswamy

AU - Zaman, M. B.

AU - Ye, Zhishen

AU - Monberg, Matthew J.

AU - Obasaju, Coleman K.

PY - 2008/1

Y1 - 2008/1

N2 - BACKGROUND: Surgical resection alone remains suboptimal for patients with early-stage (I or II) non-small cell lung cancer. Two similar randomized phase II trials were conducted to define an active preoperative regimen in this disease state. METHODS: In the first study, patients were randomized to receive gemcitabine 1000 mg/m on days 1 and 8 plus cisplatin 80 mg/m on day 1 (GC) or gemcitabine 1000 mg/m on days 1 and 8 plus carboplatin area under the curve 5.5 on day 1 (GCb). In the second trial, patients received the same regimen of GCb or gemcitabine 1000 mg/m on days 1 and 8 plus paclitaxel 200 mg/m on day 1 (GP). Cycles were repeated every 21 days for three cycles. The primary end point was pathologic complete response (pCR) rate. RESULTS: Eighty-seven eligible patients were randomized (GC n = 12, GP n = 35, and GCb n = 40), and 71 (82%) underwent surgery after chemotherapy. The confirmed pCR rate was 2.3% (2 of 87, 95% confidence interval 0.3-8.1). Clinical response rate was 28.7%, complete resection rate was 91.5% (65 of 71 patients), and perioperative mortality rate was 2.8%. As of October 2006, median survival for all patients was 45 months (65.5% censored), with 87.2% alive at 1 year and 69.8% alive at 2 years. DISCUSSION: Neoadjuvant chemotherapy with gemcitabine was feasible and well tolerated, and outcomes were similar to other reports of this treatment strategy. However, no regimen achieved the predefined pCR rate that would be sufficient to warrant further evaluation in the phase III setting. This trial design provides an efficient way of providing a rationale for choosing or rejecting regimens of potential value.

AB - BACKGROUND: Surgical resection alone remains suboptimal for patients with early-stage (I or II) non-small cell lung cancer. Two similar randomized phase II trials were conducted to define an active preoperative regimen in this disease state. METHODS: In the first study, patients were randomized to receive gemcitabine 1000 mg/m on days 1 and 8 plus cisplatin 80 mg/m on day 1 (GC) or gemcitabine 1000 mg/m on days 1 and 8 plus carboplatin area under the curve 5.5 on day 1 (GCb). In the second trial, patients received the same regimen of GCb or gemcitabine 1000 mg/m on days 1 and 8 plus paclitaxel 200 mg/m on day 1 (GP). Cycles were repeated every 21 days for three cycles. The primary end point was pathologic complete response (pCR) rate. RESULTS: Eighty-seven eligible patients were randomized (GC n = 12, GP n = 35, and GCb n = 40), and 71 (82%) underwent surgery after chemotherapy. The confirmed pCR rate was 2.3% (2 of 87, 95% confidence interval 0.3-8.1). Clinical response rate was 28.7%, complete resection rate was 91.5% (65 of 71 patients), and perioperative mortality rate was 2.8%. As of October 2006, median survival for all patients was 45 months (65.5% censored), with 87.2% alive at 1 year and 69.8% alive at 2 years. DISCUSSION: Neoadjuvant chemotherapy with gemcitabine was feasible and well tolerated, and outcomes were similar to other reports of this treatment strategy. However, no regimen achieved the predefined pCR rate that would be sufficient to warrant further evaluation in the phase III setting. This trial design provides an efficient way of providing a rationale for choosing or rejecting regimens of potential value.

KW - Early stage

KW - Gemcitabine

KW - GINEST

KW - Multimodality

KW - NSCLC

KW - Resectability

UR - http://www.scopus.com/inward/record.url?scp=37549001399&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=37549001399&partnerID=8YFLogxK

U2 - 10.1097/JTO.0b013e31815e5d9a

DO - 10.1097/JTO.0b013e31815e5d9a

M3 - Article

C2 - 18166839

AN - SCOPUS:37549001399

VL - 3

SP - 37

EP - 45

JO - Journal of Thoracic Oncology

JF - Journal of Thoracic Oncology

SN - 1556-0864

IS - 1

ER -