Concurrent chemoradiotherapy with vinorelbine and a platinum compound followed by consolidation chemotherapy for unresectable stage III non-small cell lung cancer: preliminary results of a phase II study.

Abstract

PURPOSE:

To determine the efficacy, toxicity and survival of concurrent therapy with vinorelbine and a platinum compound with radiotherapy (RT), followed by consolidation chemotherapy with the same drugs, for locally advanced non small cell lung cancer (NSCLC).

PATIENTS AND METHODS:

Fifty-seven patients with stage III NSCLC were included in this phase II study: median age 56 years (range 44-71), males / females 49/8, ECOG performance status (PS) 1/2=27/30, stage IIIA/ IIIB 11/46, squamous cell carcinoma 44, adenocarcinoma 7, adenoid cystic carcinoma 1 and large cell carcinoma 5. Treatment consisted of 2 cycles of chemotherapy with vinorelbine and cisplatin or carboplatin, given concurrently with RT, followed by 2-4 more cycles of consolidation chemotherapy with the same drugs. Twenty-two patients received amifostine for radio- and chemoprotection.

RESULTS:

Grade 3 or 4 toxicities were neutropenia and esophagitis in 19% of the patients each, and gastrointestinal toxicity in 17% of the patients. Of the 55 patients evaluable for response, 23.64% achieved complete response (CR) and 40% partial response (PR) (overall response rate 63.64%). Progression-free survival curves showed 1- and 2-year values of 42% and 21%, respectively, and median time to progression 10.5 months. The 1- and 2- year disease-specific survival was 58% and 29%, and the median overall survival 15 months.

CONCLUSION:

Preliminary analysis indicates that concurrent vinorelbine and a platinum compound with RT followed by consolidation chemotherapy with the same drugs for advanced stage III NSCLC is well tolerated, has considerable activity and positive impact on survival.

• Authors: P Rusu, T E Ciuleanu, D Cernea, D Pelau, V Gaal, C Cebotaru, T Guttman, N Todor, N Ghilezan
• Journal: Journal of B.U.ON. : official journal of the Balkan Union of Oncology (J BUON) 2007 Jan-Mar Vol. 12 Issue 1 Pg. 33-9 ISSN: 1107-0625 [Print] Cyprus
• PMID: 17436399 (Publication Type: Clinical Trial, Phase II, Journal Article)

Chemical References

• Antineoplastic Agents, Phytogenic
• Radiation-Protective Agents
• Vinblastine
• Carboplatin
• Amifostine
• Cisplatin
• Vinorelbine

Topics

• Aged
• Amifostine (therapeutic use)
• Antineoplastic Agents, Phytogenic (administration & dosage)
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Carboplatin (administration & dosage)
• Carcinoma, Non-Small-Cell Lung (drug therapy, pathology, radiotherapy)
• Chemotherapy, Adjuvant
• Cisplatin (administration & dosage)
• Disease-Free Survival
• Drug Administration Schedule
• Feasibility Studies
• Female
• Humans
• Kaplan-Meier Estimate
• Lung Neoplasms (drug therapy, radiotherapy)
• Male
• Middle Aged
• Neoplasm Invasiveness
• Neoplasm Staging
• Patient Compliance
• Radiation-Protective Agents (therapeutic use)
• Radiotherapy, Adjuvant
• Time Factors
• Treatment Outcome
• Vinblastine (administration & dosage, analogs & derivatives)
• Vinorelbine