Gemcitabine in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy: A phase II California cancer consortium trial

Primo N. Lara; Paul H. Gumerlock; Philip C. Mack; Derick H.M. Lau; Regina Gandour-Edwards; Martin J. Edelman; Kathy S. Albain; Lisa Y. Law; Jeff Longmate; Paul Frankel; Gayatri P. Reddy; Valerie Israel; James H. Doroshow; David R. Gandara

doi:10.3816/CLC.2004.n.023

Gemcitabine in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy: A phase II California cancer consortium trial

Primo N. Lara, Paul H. Gumerlock, Philip C. Mack, Derick H.M. Lau, Regina Gandour-Edwards, Martin J. Edelman, Kathy S. Albain, Lisa Y. Law, Jeff Longmate, Paul Frankel, Gayatri P. Reddy, Valerie Israel, James H. Doroshow, David R. Gandara

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Abstract

A phase II trial was designed to evaluate the efficacy and toxicity of gemcitabine in patients with non - small-cell lung cancer (NSCLC) previously treated with platinum-containing regimens and prospectively categorized for platinum response status. Treatment consisted of gemcitabine 1000 mg/m² given intravenously on days 1 and 8 of a 21-day cycle. The status of p53 in pretreatment tumor tissue was assessed by immunohistochemistry (IHC). Sixty-one patients who progressed or recurred following platinum-based therapy were enrolled, 26 platinum-sensitive and 35 platinum-refractory. A median of 4 treatment courses (range, 2-7 courses) was delivered. Of the 55 patients assessable for response, there was 1 confirmed complete response and 3 with a confirmed partial response for an overall response proportion of 7%. Twenty-one patients had stable disease while 28 progressed and 2 patients had an unconfirmed partial response. Three of the responders (2 confirmed, 1 unconfirmed) were platinum-refractory. Median progression-free survival (PFS) and overall survival for all patients were 4.1 months and 8.6 months, respectively. Median PFS and overall survival for the platinum-sensitive and platinum-refractory cohorts were 5.4 months versus 3.1 months, and 11.9 months versus 7.1 months, respectively. Toxicity was principally hematologic with grade 3/4 neutropenia in 21% and grade 4 platelets in 8%. There were no treatment-related deaths. Twenty-four of 33 patients (73%) had p53-positive tumors. Although no significant association between platinum sensitivity and p53 status was seen, patients with platinum-sensitive disease and negative p53 by IHC had a trend toward longer survival compared to those with platinum-refractory disease and/or p53 positivity (P = 0.06). We concluded that salvage gemcitabine in this dose and schedule is safe and tolerable in previously platinum-treated patients with NSCLC.

Original language	English
Pages (from-to)	102-107
Number of pages	6
Journal	Clinical Lung Cancer
Volume	6
Issue number	2
DOIs	https://doi.org/10.3816/CLC.2004.n.023
State	Published - Sep 2004

Keywords

Chemotherapy
Neutropenia
Salvage therapy
Second-line treatment
p53

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10.3816/CLC.2004.n.023

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Lara, P. N., Gumerlock, P. H., Mack, P. C., Lau, D. H. M., Gandour-Edwards, R., Edelman, M. J., Albain, K. S., Law, L. Y., Longmate, J., Frankel, P., Reddy, G. P., Israel, V., Doroshow, J. H., & Gandara, D. R. (2004). Gemcitabine in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy: A phase II California cancer consortium trial. Clinical Lung Cancer, 6(2), 102-107. https://doi.org/10.3816/CLC.2004.n.023

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title = "Gemcitabine in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy: A phase II California cancer consortium trial",

abstract = "A phase II trial was designed to evaluate the efficacy and toxicity of gemcitabine in patients with non - small-cell lung cancer (NSCLC) previously treated with platinum-containing regimens and prospectively categorized for platinum response status. Treatment consisted of gemcitabine 1000 mg/m2 given intravenously on days 1 and 8 of a 21-day cycle. The status of p53 in pretreatment tumor tissue was assessed by immunohistochemistry (IHC). Sixty-one patients who progressed or recurred following platinum-based therapy were enrolled, 26 platinum-sensitive and 35 platinum-refractory. A median of 4 treatment courses (range, 2-7 courses) was delivered. Of the 55 patients assessable for response, there was 1 confirmed complete response and 3 with a confirmed partial response for an overall response proportion of 7%. Twenty-one patients had stable disease while 28 progressed and 2 patients had an unconfirmed partial response. Three of the responders (2 confirmed, 1 unconfirmed) were platinum-refractory. Median progression-free survival (PFS) and overall survival for all patients were 4.1 months and 8.6 months, respectively. Median PFS and overall survival for the platinum-sensitive and platinum-refractory cohorts were 5.4 months versus 3.1 months, and 11.9 months versus 7.1 months, respectively. Toxicity was principally hematologic with grade 3/4 neutropenia in 21% and grade 4 platelets in 8%. There were no treatment-related deaths. Twenty-four of 33 patients (73%) had p53-positive tumors. Although no significant association between platinum sensitivity and p53 status was seen, patients with platinum-sensitive disease and negative p53 by IHC had a trend toward longer survival compared to those with platinum-refractory disease and/or p53 positivity (P = 0.06). We concluded that salvage gemcitabine in this dose and schedule is safe and tolerable in previously platinum-treated patients with NSCLC.",

keywords = "Chemotherapy, Neutropenia, Salvage therapy, Second-line treatment, p53",

author = "Lara, {Primo N.} and Gumerlock, {Paul H.} and Mack, {Philip C.} and Lau, {Derick H.M.} and Regina Gandour-Edwards and Edelman, {Martin J.} and Albain, {Kathy S.} and Law, {Lisa Y.} and Jeff Longmate and Paul Frankel and Reddy, {Gayatri P.} and Valerie Israel and Doroshow, {James H.} and Gandara, {David R.}",

year = "2004",

month = sep,

doi = "10.3816/CLC.2004.n.023",

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Lara, PN, Gumerlock, PH, Mack, PC, Lau, DHM, Gandour-Edwards, R, Edelman, MJ, Albain, KS, Law, LY, Longmate, J, Frankel, P, Reddy, GP, Israel, V, Doroshow, JH & Gandara, DR 2004, 'Gemcitabine in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy: A phase II California cancer consortium trial', Clinical Lung Cancer, vol. 6, no. 2, pp. 102-107. https://doi.org/10.3816/CLC.2004.n.023

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T1 - Gemcitabine in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy

T2 - A phase II California cancer consortium trial

AU - Lara, Primo N.

AU - Gumerlock, Paul H.

AU - Mack, Philip C.

AU - Lau, Derick H.M.

AU - Gandour-Edwards, Regina

AU - Edelman, Martin J.

AU - Albain, Kathy S.

AU - Law, Lisa Y.

AU - Longmate, Jeff

AU - Frankel, Paul

AU - Reddy, Gayatri P.

AU - Israel, Valerie

AU - Doroshow, James H.

AU - Gandara, David R.

PY - 2004/9

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N2 - A phase II trial was designed to evaluate the efficacy and toxicity of gemcitabine in patients with non - small-cell lung cancer (NSCLC) previously treated with platinum-containing regimens and prospectively categorized for platinum response status. Treatment consisted of gemcitabine 1000 mg/m2 given intravenously on days 1 and 8 of a 21-day cycle. The status of p53 in pretreatment tumor tissue was assessed by immunohistochemistry (IHC). Sixty-one patients who progressed or recurred following platinum-based therapy were enrolled, 26 platinum-sensitive and 35 platinum-refractory. A median of 4 treatment courses (range, 2-7 courses) was delivered. Of the 55 patients assessable for response, there was 1 confirmed complete response and 3 with a confirmed partial response for an overall response proportion of 7%. Twenty-one patients had stable disease while 28 progressed and 2 patients had an unconfirmed partial response. Three of the responders (2 confirmed, 1 unconfirmed) were platinum-refractory. Median progression-free survival (PFS) and overall survival for all patients were 4.1 months and 8.6 months, respectively. Median PFS and overall survival for the platinum-sensitive and platinum-refractory cohorts were 5.4 months versus 3.1 months, and 11.9 months versus 7.1 months, respectively. Toxicity was principally hematologic with grade 3/4 neutropenia in 21% and grade 4 platelets in 8%. There were no treatment-related deaths. Twenty-four of 33 patients (73%) had p53-positive tumors. Although no significant association between platinum sensitivity and p53 status was seen, patients with platinum-sensitive disease and negative p53 by IHC had a trend toward longer survival compared to those with platinum-refractory disease and/or p53 positivity (P = 0.06). We concluded that salvage gemcitabine in this dose and schedule is safe and tolerable in previously platinum-treated patients with NSCLC.

AB - A phase II trial was designed to evaluate the efficacy and toxicity of gemcitabine in patients with non - small-cell lung cancer (NSCLC) previously treated with platinum-containing regimens and prospectively categorized for platinum response status. Treatment consisted of gemcitabine 1000 mg/m2 given intravenously on days 1 and 8 of a 21-day cycle. The status of p53 in pretreatment tumor tissue was assessed by immunohistochemistry (IHC). Sixty-one patients who progressed or recurred following platinum-based therapy were enrolled, 26 platinum-sensitive and 35 platinum-refractory. A median of 4 treatment courses (range, 2-7 courses) was delivered. Of the 55 patients assessable for response, there was 1 confirmed complete response and 3 with a confirmed partial response for an overall response proportion of 7%. Twenty-one patients had stable disease while 28 progressed and 2 patients had an unconfirmed partial response. Three of the responders (2 confirmed, 1 unconfirmed) were platinum-refractory. Median progression-free survival (PFS) and overall survival for all patients were 4.1 months and 8.6 months, respectively. Median PFS and overall survival for the platinum-sensitive and platinum-refractory cohorts were 5.4 months versus 3.1 months, and 11.9 months versus 7.1 months, respectively. Toxicity was principally hematologic with grade 3/4 neutropenia in 21% and grade 4 platelets in 8%. There were no treatment-related deaths. Twenty-four of 33 patients (73%) had p53-positive tumors. Although no significant association between platinum sensitivity and p53 status was seen, patients with platinum-sensitive disease and negative p53 by IHC had a trend toward longer survival compared to those with platinum-refractory disease and/or p53 positivity (P = 0.06). We concluded that salvage gemcitabine in this dose and schedule is safe and tolerable in previously platinum-treated patients with NSCLC.

KW - Chemotherapy

KW - Neutropenia

KW - Salvage therapy

KW - Second-line treatment

KW - p53

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DO - 10.3816/CLC.2004.n.023

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SN - 1525-7304

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Gemcitabine in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy: A phase II California cancer consortium trial

Abstract

Keywords

UN SDGs

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