Abstract
A growing number of patients, mainly cisplatin-pretreated, require second-line therapy for non-small cell lung cancer (NSCLC) but the optimal treatment and appropriate criteria for patient selection have not been defined yet. A second-line phase II study was conducted in cisplatin-pretreated patients with advanced NSCLC to evaluate the activity and toxicity of weekly paclitaxel. Fifty-three consecutive NSCLC patients (9 stage IIIA-B, 44 stage IV) progressing after one front line cisplatin-based chemotherapy were enrolled. Previous treatment with taxanes was not allowed. Patients with stage III were also pretreated with thoracic radiotherapy. Weekly paclitaxel was administered as 1-h infusion at a dose of 80mg/m2 for three weeks with one week off, for a maximum of four courses. All patients were assessable for response, toxicity and survival. A complete response was observed in one case, partial response in 7, for an overall response rate (RR) of 15%, (95% CI=5-25%). Stable disease (SD) was registered in 11 patients, for an overall clinical benefit (CB=RR+SD) of 36% (95% CI=23-49%). Toxicity was mild, with G3-4 neutropenia and thrombocytopenia in 6 and 2% of patients, respectively. Non-hematological toxicities were negligible. No significant correlation between patient or treatment-related variable and RR was observed. CB was significantly higher in patients with non-squamous histology (P=0.03) and no progression within 4 months of first line cisplatin-based chemotherapy (P=0.007). Median progression-free survival (PFS) was 7 months in responders and 4 months in pts with SD. PFS was significantly related to good performance status (PS) (P=0.002) and non-squamous histology (P=0.004). In conclusion, weekly paclitaxel has acceptable palliative activity and excellent tolerance in cisplatin-pretreated patients. Patients with PS 0-1, non-squamous histology and with no progression within 4 months of first line cisplatin-based chemotherapy seem more likely to benefit from this treatment.
| Original language | English |
|---|---|
| Pages (from-to) | 231-239 |
| Number of pages | 9 |
| Journal | Lung Cancer |
| Volume | 44 |
| Issue number | 2 |
| DOIs | |
| Publication status | Published - May 2004 |
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Keywords
- Chemotherapy
- Non-Small Cell Lung Cancer
- Paclitaxel
- Second-line treatment
ASJC Scopus subject areas
- Oncology
Cite this
Phase II study of weekly paclitaxel as second-line therapy in patients with advanced non-small cell lung cancer. / Ceresoli, Giovanni Luca; Gregorc, Vanesa; Cordio, Stefano; Bencardino, Katia Bruna; Schipani, Stefano; Cozzarini, Cesare; Bordonaro, Roberto; Villa, Eugenio.
In: Lung Cancer, Vol. 44, No. 2, 05.2004, p. 231-239.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Phase II study of weekly paclitaxel as second-line therapy in patients with advanced non-small cell lung cancer
AU - Ceresoli, Giovanni Luca
AU - Gregorc, Vanesa
AU - Cordio, Stefano
AU - Bencardino, Katia Bruna
AU - Schipani, Stefano
AU - Cozzarini, Cesare
AU - Bordonaro, Roberto
AU - Villa, Eugenio
PY - 2004/5
Y1 - 2004/5
N2 - A growing number of patients, mainly cisplatin-pretreated, require second-line therapy for non-small cell lung cancer (NSCLC) but the optimal treatment and appropriate criteria for patient selection have not been defined yet. A second-line phase II study was conducted in cisplatin-pretreated patients with advanced NSCLC to evaluate the activity and toxicity of weekly paclitaxel. Fifty-three consecutive NSCLC patients (9 stage IIIA-B, 44 stage IV) progressing after one front line cisplatin-based chemotherapy were enrolled. Previous treatment with taxanes was not allowed. Patients with stage III were also pretreated with thoracic radiotherapy. Weekly paclitaxel was administered as 1-h infusion at a dose of 80mg/m2 for three weeks with one week off, for a maximum of four courses. All patients were assessable for response, toxicity and survival. A complete response was observed in one case, partial response in 7, for an overall response rate (RR) of 15%, (95% CI=5-25%). Stable disease (SD) was registered in 11 patients, for an overall clinical benefit (CB=RR+SD) of 36% (95% CI=23-49%). Toxicity was mild, with G3-4 neutropenia and thrombocytopenia in 6 and 2% of patients, respectively. Non-hematological toxicities were negligible. No significant correlation between patient or treatment-related variable and RR was observed. CB was significantly higher in patients with non-squamous histology (P=0.03) and no progression within 4 months of first line cisplatin-based chemotherapy (P=0.007). Median progression-free survival (PFS) was 7 months in responders and 4 months in pts with SD. PFS was significantly related to good performance status (PS) (P=0.002) and non-squamous histology (P=0.004). In conclusion, weekly paclitaxel has acceptable palliative activity and excellent tolerance in cisplatin-pretreated patients. Patients with PS 0-1, non-squamous histology and with no progression within 4 months of first line cisplatin-based chemotherapy seem more likely to benefit from this treatment.
AB - A growing number of patients, mainly cisplatin-pretreated, require second-line therapy for non-small cell lung cancer (NSCLC) but the optimal treatment and appropriate criteria for patient selection have not been defined yet. A second-line phase II study was conducted in cisplatin-pretreated patients with advanced NSCLC to evaluate the activity and toxicity of weekly paclitaxel. Fifty-three consecutive NSCLC patients (9 stage IIIA-B, 44 stage IV) progressing after one front line cisplatin-based chemotherapy were enrolled. Previous treatment with taxanes was not allowed. Patients with stage III were also pretreated with thoracic radiotherapy. Weekly paclitaxel was administered as 1-h infusion at a dose of 80mg/m2 for three weeks with one week off, for a maximum of four courses. All patients were assessable for response, toxicity and survival. A complete response was observed in one case, partial response in 7, for an overall response rate (RR) of 15%, (95% CI=5-25%). Stable disease (SD) was registered in 11 patients, for an overall clinical benefit (CB=RR+SD) of 36% (95% CI=23-49%). Toxicity was mild, with G3-4 neutropenia and thrombocytopenia in 6 and 2% of patients, respectively. Non-hematological toxicities were negligible. No significant correlation between patient or treatment-related variable and RR was observed. CB was significantly higher in patients with non-squamous histology (P=0.03) and no progression within 4 months of first line cisplatin-based chemotherapy (P=0.007). Median progression-free survival (PFS) was 7 months in responders and 4 months in pts with SD. PFS was significantly related to good performance status (PS) (P=0.002) and non-squamous histology (P=0.004). In conclusion, weekly paclitaxel has acceptable palliative activity and excellent tolerance in cisplatin-pretreated patients. Patients with PS 0-1, non-squamous histology and with no progression within 4 months of first line cisplatin-based chemotherapy seem more likely to benefit from this treatment.
KW - Chemotherapy
KW - Non-Small Cell Lung Cancer
KW - Paclitaxel
KW - Second-line treatment
UR - http://www.scopus.com/inward/record.url?scp=1842685104&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=1842685104&partnerID=8YFLogxK
U2 - 10.1016/j.lungcan.2003.11.006
DO - 10.1016/j.lungcan.2003.11.006
M3 - Article
C2 - 15084388
AN - SCOPUS:1842685104
VL - 44
SP - 231
EP - 239
JO - Lung Cancer
JF - Lung Cancer
SN - 0169-5002
IS - 2
ER -