Second line treatment of recurrent glioblastoma with sunitinib: results of a phase II study and systematic review of literature

PURPOSE: The aim of the present phase II study was to evaluate the efficacy of the paclitaxel, ifosfamide, and cisplatin (PIC) combination in relapsed small-cell lung cancer (SCLC). PATIENTS AND METHODS: Eligible patients were those with SCLC who had progressed or relapsed after therapy with carboplatin and etoposide (with or without chest radiotherapy). The PIC regimen consisted of paclitaxel 175 mg/m2 on day 1, ifosfamide 5 g/m2 divided over days 1 and 2, and cisplatin 100 mg/m2 divided over days 1 and 2; PIC was given every 21 days with granulocyte colony-stimulating factor support. RESULTS: Thirty-three patients (30 men and three women) were entered onto the study (median age, 62 years [range, 55 to 70 years]; median performance status, 1 [range, 0 to 2]). Metastatic sites at study entry included the lymph nodes (n = 13 patients), bone (n = 9), liver (n = 5), brain (n = 6), lung nodules (n = 8), adrenal glands (n = 9), and other (n = 2) Responses included eight complete remissions and 16 partial remissions (overall response rate, 73% [24 of 33 patients]). Five patients had stable disease and two had progressive disease. Median time to progression and overall survival were 21 and 28 weeks, respectively. The 1-year survival rate was 12%, with two patients alive without evidence of disease at 76 and 104 weeks since PIC initiation. Grade 3 and 4 toxicities included neutropenia in 30 patients (24 [73%] developed grade 4 neutropenia [ < 5 days]) and febrile neutropenia in six patients (18%); grade 3 or 4 thrombocytopenia was seen in nine patients (27%) . No grade 3 neuropathy was observed; grade 1 or 2 CNS toxicity was seen in five patients, there was no renal toxicity, grade 2 myalgias were seen in nine patients, grade 2 diarrhea was seen in one patient, and grade 3 nausea or vomiting was seen in seven patients. There were no treatment-related deaths. CONCLUSION: In the present phase II study, the PIC combination seemed highly active and tolerable in patients with relapsed SCLC when it was administered as second-line treatment. Given the present experience, an evaluation of the PIC regimen as front-line treatment of SCLC is planned.

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Vinorelbine as second line treatment in anthracycline pre-treated advanced breast cancer patients: A phase II study

European Journal of Cancer ◽

10.1016/0959-8049(93)91052-m ◽

1993 ◽

Vol 29 ◽

pp. S82 ◽

Cited By ~ 4

Author(s):

L. Dogliotti ◽

G. Gorzegno ◽

M.G. Bau ◽

A. Farris ◽

C. Bumma ◽

...

Keyword(s):

Breast Cancer ◽

Advanced Breast Cancer ◽

Cancer Patients ◽

Phase Ii ◽

Phase Ii Study ◽

Advanced Breast ◽

Line Treatment ◽

Second Line ◽

Breast Cancer Patients

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Randomized phase II study of three doses of the integrin inhibitor cilengitide versus docetaxel as second-line treatment for patients with advanced non-small-cell lung cancer

Investigational New Drugs ◽

10.1007/s10637-012-9842-6 ◽

2012 ◽

Vol 31 (1) ◽

pp. 175-182 ◽

Cited By ~ 39

Author(s):

Christian Manegold ◽

Johan Vansteenkiste ◽

Felipe Cardenal ◽

Wolfgang Schuette ◽

Penella J. Woll ◽

...

Keyword(s):

Lung Cancer ◽

Small Cell Lung Cancer ◽

Phase Ii ◽

Phase Ii Study ◽

Small Cell ◽

Line Treatment ◽

Second Line ◽

Small Cell Lung ◽

Randomized Phase Ii ◽

Integrin Inhibitor

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Topotecan, an active drug in the second-line treatment of epithelial ovarian cancer: results of a large European phase II study.

Journal of Clinical Oncology ◽

10.1200/jco.1996.14.12.3056 ◽

1996 ◽

Vol 14 (12) ◽

pp. 3056-3061 ◽

Cited By ~ 273

Author(s):

G J Creemers ◽

G Bolis ◽

M Gore ◽

G Scarfone ◽

A J Lacave ◽

...

Keyword(s):

Ovarian Cancer ◽

Phase Ii ◽

Topoisomerase I ◽

Phase Ii Study ◽

Dose Intensity ◽

Complete Response ◽

Subsequent Treatment ◽

Line Treatment ◽

Second Line ◽

Chemotherapeutic Regimen

PURPOSE Topotecan is a topoisomerase I inhibitor with preclinical activity against various tumor types. We conducted a large multicenter phase II study with topotecan in ovarian cancer in patients who had failed to respond to one prior cisplatin-based chemotherapeutic regimen. PATIENTS AND METHODS Topotecan 1.5 mg/m2/d was administered intravenously by 30-minute infusion for 5 days repeated every 3 weeks. As the cisplatin-free interval relates to response in subsequent treatment, patients were stratified in subgroups, ie, cisplatin-refractory, cisplatin-resistant, and cisplatin-sensitive. RESULTS One-hundred eleven patients entered the study. Nineteen patients were considered to be ineligible; 92 patients were assessable for response. A total of 552 courses were given (median, four per patient; range, one to 17). The major toxicities were leukocytopenia and neutropenia, which were grade 3 to 4 in 54.2% and 69.1% of courses, respectively, but with only 4.3% of these being grade 4 neutropenia plus fever or infectious complications. Prophylactic granulocyte colony-stimulating factor (G-CSF) was given in 20.5% of courses to maintain dose-intensity. Other relatively frequent side effects were alopecia (82%), nausea (36.4%), and vomiting (17.5%). The overall response rate was 16.3%, with one complete response (CR) and 14 partial responses (PRs). In the cisplatin-refractory, cisplatin-resistant, and cisplatin-sensitive strata, the response rates were 5.9%, 17.8%, and 26.7%, respectively. The median duration of time of documented response was 21.7 weeks (range, 4.6 to 41.9). CONCLUSION Topotecan in a daily-times-five schedule is an effective regimen as second-line treatment in ovarian cancer. Further investigations of topotecan in ovarian cancer, including first-line use and combination with other active agents, are indicated.

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