Phase II study of weekly paclitaxel as second-line therapy in patients with advanced non-small cell lung cancer

Giovanni Luca Ceresoli, Vanesa Gregorc, Stefano Cordio, Katia Bruna Bencardino, Stefano Schipani, Cesare Cozzarini, Roberto Bordonaro, Eugenio Villa

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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 languageEnglish
Pages (from-to)231-239
Number of pages9
JournalLung Cancer
Volume44
Issue number2
DOIs
Publication statusPublished - May 2004

Fingerprint

Paclitaxel
Non-Small Cell Lung Carcinoma
Cisplatin
Therapeutics
Histology
Drug Therapy
Disease-Free Survival
Taxoids
Neutropenia
Patient Selection
Radiotherapy
Thorax
Survival

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 journalArticle

Ceresoli, GL, Gregorc, V, Cordio, S, Bencardino, KB, Schipani, S, Cozzarini, C, Bordonaro, R & Villa, E 2004, 'Phase II study of weekly paclitaxel as second-line therapy in patients with advanced non-small cell lung cancer', Lung Cancer, vol. 44, no. 2, pp. 231-239. https://doi.org/10.1016/j.lungcan.2003.11.006
Ceresoli, Giovanni Luca ; Gregorc, Vanesa ; Cordio, Stefano ; Bencardino, Katia Bruna ; Schipani, Stefano ; Cozzarini, Cesare ; Bordonaro, Roberto ; Villa, Eugenio. / Phase II study of weekly paclitaxel as second-line therapy in patients with advanced non-small cell lung cancer. In: Lung Cancer. 2004 ; Vol. 44, No. 2. pp. 231-239.
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AU - Schipani, Stefano

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