Phase II study of second-line gemcitabine in sensitive or refractory small cell lung cancer

Tien Hoang, KyungMann Kim, Anthony Jaslowski, Paul Koch, Peter Beatty, James McGovern, Maria Quisumbing, Gary Shapiro, Robert Witte, Joan H. Schiller

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Abstract

Small cell lung cancer (SCLC) is highly sensitive to chemotherapy. Despite a dramatic initial response, however, most patients relapse. Given the activity of gemcitabine in non-small cell lung cancer (NSCLC), and early clinical trials suggesting activity of gemcitabine in chemo-naive SCLC patients, we conducted a phase II study to determine the efficacy and toxicities of gemcitabine in SCLC patients who have failed first-line chemotherapy. Gemcitabine 1250 mg/m 2 was given intravenously on days 1 and 8, every 3 weeks. Eligibility criteria included prior treatment with only one chemotherapy regimen and Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. Patients with brain metastases were eligible. Results: Between April 1998 and October 2001, 27 patients were enrolled: 15 patients with sensitive (S) disease (recurred>3 months after first-line chemotherapy) and 12 patients with refractory (R) disease (failed<3 months after first-line chemotherapy). Median age was 61 (range 45-74). All patients had received prior platinum-based therapy involving etoposide and either cisplatin or carboplatin. There were one early death and two early withdrawals because of toxicity. No responses were observed. Of 24 patients who received at least two cycles of gemcitabine, only three achieved stable disease after six cycles while 21 progressed. The median time to progression (TTP) was 6 weeks in S group, 5.6 weeks in R group, and 6 weeks overall. After a minimum potential follow-up of almost 1 year for all patients, the median survival was 8.8 months in S group, 4.2 months in R group, and 6.4 months for the whole group. One-year survival rate was 33.3% in S group, 16.7% in R group, and 25.4% for all patients. Myelosuppression was the most commonly observed adverse effect, with grade 3/4 neutropenia in 30%, and grade 3 thrombocytopenia in 30%. One patient (3.7%) developed neutropenic fever. Respiratory failure and death, possibly related to pulmonary toxicity, was observed in one patient (3.7%). Conclusion: monotherapy gemcitabine as second-line agent has limited activity in previously treated SCLC.

Original languageEnglish (US)
Pages (from-to)97-102
Number of pages6
JournalLung Cancer
Volume42
Issue number1
DOIs
StatePublished - Oct 1 2003

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gemcitabine
Small Cell Lung Carcinoma
Drug Therapy

Keywords

  • Gemcitabine
  • Refractory
  • Sensitive
  • Small cell lung cancer

ASJC Scopus subject areas

  • Oncology

Cite this

Hoang, T., Kim, K., Jaslowski, A., Koch, P., Beatty, P., McGovern, J., ... Schiller, J. H. (2003). Phase II study of second-line gemcitabine in sensitive or refractory small cell lung cancer. Lung Cancer, 42(1), 97-102. https://doi.org/10.1016/S0169-5002(03)00273-3

Phase II study of second-line gemcitabine in sensitive or refractory small cell lung cancer. / Hoang, Tien; Kim, KyungMann; Jaslowski, Anthony; Koch, Paul; Beatty, Peter; McGovern, James; Quisumbing, Maria; Shapiro, Gary; Witte, Robert; Schiller, Joan H.

In: Lung Cancer, Vol. 42, No. 1, 01.10.2003, p. 97-102.

Research output: Contribution to journalArticle

Hoang, T, Kim, K, Jaslowski, A, Koch, P, Beatty, P, McGovern, J, Quisumbing, M, Shapiro, G, Witte, R & Schiller, JH 2003, 'Phase II study of second-line gemcitabine in sensitive or refractory small cell lung cancer', Lung Cancer, vol. 42, no. 1, pp. 97-102. https://doi.org/10.1016/S0169-5002(03)00273-3
Hoang, Tien ; Kim, KyungMann ; Jaslowski, Anthony ; Koch, Paul ; Beatty, Peter ; McGovern, James ; Quisumbing, Maria ; Shapiro, Gary ; Witte, Robert ; Schiller, Joan H. / Phase II study of second-line gemcitabine in sensitive or refractory small cell lung cancer. In: Lung Cancer. 2003 ; Vol. 42, No. 1. pp. 97-102.
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abstract = "Small cell lung cancer (SCLC) is highly sensitive to chemotherapy. Despite a dramatic initial response, however, most patients relapse. Given the activity of gemcitabine in non-small cell lung cancer (NSCLC), and early clinical trials suggesting activity of gemcitabine in chemo-naive SCLC patients, we conducted a phase II study to determine the efficacy and toxicities of gemcitabine in SCLC patients who have failed first-line chemotherapy. Gemcitabine 1250 mg/m 2 was given intravenously on days 1 and 8, every 3 weeks. Eligibility criteria included prior treatment with only one chemotherapy regimen and Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. Patients with brain metastases were eligible. Results: Between April 1998 and October 2001, 27 patients were enrolled: 15 patients with sensitive (S) disease (recurred>3 months after first-line chemotherapy) and 12 patients with refractory (R) disease (failed<3 months after first-line chemotherapy). Median age was 61 (range 45-74). All patients had received prior platinum-based therapy involving etoposide and either cisplatin or carboplatin. There were one early death and two early withdrawals because of toxicity. No responses were observed. Of 24 patients who received at least two cycles of gemcitabine, only three achieved stable disease after six cycles while 21 progressed. The median time to progression (TTP) was 6 weeks in S group, 5.6 weeks in R group, and 6 weeks overall. After a minimum potential follow-up of almost 1 year for all patients, the median survival was 8.8 months in S group, 4.2 months in R group, and 6.4 months for the whole group. One-year survival rate was 33.3{\%} in S group, 16.7{\%} in R group, and 25.4{\%} for all patients. Myelosuppression was the most commonly observed adverse effect, with grade 3/4 neutropenia in 30{\%}, and grade 3 thrombocytopenia in 30{\%}. One patient (3.7{\%}) developed neutropenic fever. Respiratory failure and death, possibly related to pulmonary toxicity, was observed in one patient (3.7{\%}). Conclusion: monotherapy gemcitabine as second-line agent has limited activity in previously treated SCLC.",
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AU - Kim, KyungMann

AU - Jaslowski, Anthony

AU - Koch, Paul

AU - Beatty, Peter

AU - McGovern, James

AU - Quisumbing, Maria

AU - Shapiro, Gary

AU - Witte, Robert

AU - Schiller, Joan H.

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N2 - Small cell lung cancer (SCLC) is highly sensitive to chemotherapy. Despite a dramatic initial response, however, most patients relapse. Given the activity of gemcitabine in non-small cell lung cancer (NSCLC), and early clinical trials suggesting activity of gemcitabine in chemo-naive SCLC patients, we conducted a phase II study to determine the efficacy and toxicities of gemcitabine in SCLC patients who have failed first-line chemotherapy. Gemcitabine 1250 mg/m 2 was given intravenously on days 1 and 8, every 3 weeks. Eligibility criteria included prior treatment with only one chemotherapy regimen and Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. Patients with brain metastases were eligible. Results: Between April 1998 and October 2001, 27 patients were enrolled: 15 patients with sensitive (S) disease (recurred>3 months after first-line chemotherapy) and 12 patients with refractory (R) disease (failed<3 months after first-line chemotherapy). Median age was 61 (range 45-74). All patients had received prior platinum-based therapy involving etoposide and either cisplatin or carboplatin. There were one early death and two early withdrawals because of toxicity. No responses were observed. Of 24 patients who received at least two cycles of gemcitabine, only three achieved stable disease after six cycles while 21 progressed. The median time to progression (TTP) was 6 weeks in S group, 5.6 weeks in R group, and 6 weeks overall. After a minimum potential follow-up of almost 1 year for all patients, the median survival was 8.8 months in S group, 4.2 months in R group, and 6.4 months for the whole group. One-year survival rate was 33.3% in S group, 16.7% in R group, and 25.4% for all patients. Myelosuppression was the most commonly observed adverse effect, with grade 3/4 neutropenia in 30%, and grade 3 thrombocytopenia in 30%. One patient (3.7%) developed neutropenic fever. Respiratory failure and death, possibly related to pulmonary toxicity, was observed in one patient (3.7%). Conclusion: monotherapy gemcitabine as second-line agent has limited activity in previously treated SCLC.

AB - Small cell lung cancer (SCLC) is highly sensitive to chemotherapy. Despite a dramatic initial response, however, most patients relapse. Given the activity of gemcitabine in non-small cell lung cancer (NSCLC), and early clinical trials suggesting activity of gemcitabine in chemo-naive SCLC patients, we conducted a phase II study to determine the efficacy and toxicities of gemcitabine in SCLC patients who have failed first-line chemotherapy. Gemcitabine 1250 mg/m 2 was given intravenously on days 1 and 8, every 3 weeks. Eligibility criteria included prior treatment with only one chemotherapy regimen and Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. Patients with brain metastases were eligible. Results: Between April 1998 and October 2001, 27 patients were enrolled: 15 patients with sensitive (S) disease (recurred>3 months after first-line chemotherapy) and 12 patients with refractory (R) disease (failed<3 months after first-line chemotherapy). Median age was 61 (range 45-74). All patients had received prior platinum-based therapy involving etoposide and either cisplatin or carboplatin. There were one early death and two early withdrawals because of toxicity. No responses were observed. Of 24 patients who received at least two cycles of gemcitabine, only three achieved stable disease after six cycles while 21 progressed. The median time to progression (TTP) was 6 weeks in S group, 5.6 weeks in R group, and 6 weeks overall. After a minimum potential follow-up of almost 1 year for all patients, the median survival was 8.8 months in S group, 4.2 months in R group, and 6.4 months for the whole group. One-year survival rate was 33.3% in S group, 16.7% in R group, and 25.4% for all patients. Myelosuppression was the most commonly observed adverse effect, with grade 3/4 neutropenia in 30%, and grade 3 thrombocytopenia in 30%. One patient (3.7%) developed neutropenic fever. Respiratory failure and death, possibly related to pulmonary toxicity, was observed in one patient (3.7%). Conclusion: monotherapy gemcitabine as second-line agent has limited activity in previously treated SCLC.

KW - Gemcitabine

KW - Refractory

KW - Sensitive

KW - Small cell lung cancer

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