Randomized study of vinorelbine and cisplatin versus vindesine and cisplatin versus vinorelbine alone in advanced non-small-cell lung cancer: results of a European multicenter trial including 612 patients.

Chevalier, Thierry Le; Brisgand, D.; Douillard, Jean Yves; Pujol, Jean Louis; Alberola, V.; Monnier, Alain; Rivière, Alain; Lianes, P.; Chomy, P; Cigolari, S.

doi:10.1200/jco.1994.12.2.360

Cited by 759 publications

(336 citation statements)

References 20 publications

Supporting

Mentioning

313

Contrasting

Unclassified

Order By: Relevance

“…The treatment outcomes of the present study were superior or at least comparable to the results of previous multi-institutional trials of a combination of CPT-11 plus CDDP (Masuda et al, 1998(Masuda et al, , 1999DeVore et al, 1999;Niho et al, 1999). Recently, superiority of 2-drug combinations of one of the newly developed agents, vinorelbine or paclitaxel, with CDDP to the representative CDDP-based chemotherapy in the 1980s such as CDDP plus vindesine or etoposide was reported in prospective randomized trials (Le Chevalier et al, 1994;Bonomi et al, 2000). However, no definitive conclusion was obtained in the 2 Japanese multi-institutional randomized trials comparing CPT-11 plus CDDP with CDDP plus vindesine (Masuda et al, 1999;Niho et al, 1999), although superiority of CPT-11 plus CDDP for stage IV patients was shown by the subset analysis of one trial (Masuda et al, 1999).…”

Section: Discussionmentioning

confidence: 99%

Fractionated administration of irinotecan and cisplatin for treatment of non-small-cell lung cancer: a phase II study of Okayama Lung Cancer Study Group

et al. 2001

View full text Add to dashboard Cite

A phase II study of fractionated administration of irinotecan (CPT-11) and cisplatin (CDDP) in patients with non-small-cell lung cancer (NSCLC) was conducted. Between January 1996 and January 1998, 44 previously untreated patients with stage IIIB or IV NSCLC were enrolled. CDDP at a dose of 60 mg m –2 was given first and followed by CPT-11 at a dose of 50 mg m –2 . Both drugs were given by 1-hour infusion on days 1 and 8, and repeated every 4 weeks up to 4 cycles. 42 patients were evaluated for response and 44 for survival and toxicity. 20 patients (48%: 95% confidence interval 32–63%) achieved an objective response. The median duration of responses was 8 months, and the median survival time and the 1-year survival rate were 12.5 months and 56.8%, respectively. Major toxicities were neutropenia and diarrhoea. Grade 3 or 4 neutropenia occurred in 70.5% of the patients and one patient died of sepsis. Grade 3 or 4 diarrhoea was experienced in 25.0%, but manageable by conventional therapy. In conclusion, fractionated administration of CPT-11 and CDDP was highly effective for advanced NSCLC with manageable toxicities. © 2001 Cancer Research Campaign http://www.bjcancer.com

show abstract

Section: Discussionmentioning

confidence: 99%

Fractionated administration of irinotecan and cisplatin for treatment of non-small-cell lung cancer: a phase II study of Okayama Lung Cancer Study Group

et al. 2001

View full text Add to dashboard Cite

show abstract

“…16 -19 A large, pivotal European Phase III trial compared single-agent vinorelbine with vinorelbine/cisplatin as well as with the European standard of vindesine/cisplatin. 20 Cisplatin/ vinorelbine significantly improved the response rate compared with cisplatin/vindesine and single-agent vinorelbine (30% versus 19% and 14%, respectively). Median length of survival was also significantly better (40 weeks versus 32 weeks and 31 weeks).…”

mentioning

confidence: 91%

The novel and effective nonplatinum, nontaxane combination of gemcitabine and vinorelbine in advanced nonsmall cell lung carcinoma

Herbst

Khuri

et al. 2002

Cancer

View full text Add to dashboard Cite

BACKGROUNDGemcitabine and vinorelbine are two of the most active third‐generation agents for the treatment of advanced nonsmall cell lung carcinoma (NSCLC). The authors conducted a formal Phase II trial to evaluate the efficacy of this combination in both untreated and previously treated patients with Stage IIIB (with pleural effusion) or Stage IV NSCLC.METHODSA total of 78 patients were treated on the current Phase II trial of front‐line or second/third‐line therapy with gemcitabine and vinorelbine in NSCLC. Eligible patients manifested either untreated disease (n = 42) or had received at least one but not more than two prior chemotherapy regimens (n = 36). The median age was 59 years (range, 33–79) with 57 men (73%) and 21 women (27%). The median performance status was one (range, one to two). The initial eight patients (four untreated and four previously treated) were treated at a previously established maximum tolerated dose of vinorelbine (30 mg/m2) and gemcitabine (1000 mg/m2) on Days 1, 8, and 15, with significant myelosuppression seen in five out of eight patients requiring dose omission in the first cycle. The next 70 patients received a reduced dose of vinorelbine (25 mg/m2) followed by gemcitabine (900 mg/m2) on Days 1, 8, and 15.RESULTSSeventy eight patients were treated. Fifteen (36%) of the 42 evaluable patients who received front‐line therapy had objective responses and 14 (33%) had stable disease. In the patients with prior treatment, 6 (17%) of 36 patients had partial response and 18 patients (50%) had stable disease. Median survival time for the previously untreated patient group was 10.1 months, with a one year survival of 43% and a two year survival rate of 32%. For the previously treated patients, the median survival time was 8.5 months, with a one year survival rate of 30%. Toxic effects were notable for significant myelosuppression, with ≥Grade 3 granulocytopenia seen in 55% of the patients on the untreated arm and 67% of the patients on the previously untreated arm. Additionally, 9.5% and 13.9% (untreated and previously treated), respectively, of these patients experienced Grades 3 and 4 thrombocytopenia at some point in their treatment. A full dose delivery analysis showed that this myelosuppression resulted in Course 1, Day 15 skipped doses (even at the reduced dose level) in 42% of previously untreated patients and 47% of pretreated patients. Other side effects seen at Grades 3 and 4 in previously untreated and treated patients included anemia (9.5% and 2.8%), asthenia (4.8% and 5.5%), infection (14.3% and 5.6%), pain (9.5% and 19.4%), and pulmonary complications (4.8% and 13.8%).CONCLUSIONSGemcitabine/vinorelbine is an active, well‐tolerated combination in both front‐line and second/third‐line therapy for Stage IIIB/IV NSCLC. The response rate, median survival rate, and one year survival rate compare favorably with platinum‐based regimens. The toxicity profile of the gemcitabine/vinorelbine combination was quite favorable, with minimal Grade 3 and 4 toxic effects aside from granulocytopenia, which resulted in numerous Day 15 skipped doses but no significant febrile neutropenia or infection. The combination of gemcitabine and vinorelbine could be a useful regimen in standard clinical practice and has the potential for efficient combination with biologic/targeted therapy. Multiple randomized trials of this combination versus platinum combinations are now ongoing. Cancer 2002;95:340–353. © 2002 American Cancer Society.DOI 10.1002/cncr.10629

show abstract

“…9,10 Recently, advances have been made in understanding the biology of hormone-refractory prostate carcinoma, which is elucidating potential targets for new drugs. 11 Vinorelbine is a new semisynthetic vinca-alkaloid derivative with antimicrotubular activity that has shown to be highly effective in small-cell lung cancer compared with vinblastine and vindesine 12,13 and in hormonedependent tumours such as breast cancer. 14 Moreover, it has less neurotoxicity because it has limited effects on the axonal microtubules.…”

Section: Introductionmentioning

confidence: 99%

Mitoxantrone, vinorelbine and prednisone (MVD) in the treatment of metastatic hormonoresistant prostate cancer — a phase II trial

Bernardi

Talamini

Zanetti

et al. 2004

Prostate Cancer Prostatic Dis

View full text Add to dashboard Cite

A total of 28 patients were treated with mitoxantrone, vinorelbine and prednisone every 3 weeks. In all, 11 patients (46%) had a significant prostate-specific antigen decline for a median duration of 11.4 months. Eight patients (33%) achieved a partial response on pain, while seven (29%) obtained a stabilisation of the symptom. Median duration of the response was 9.5 months. A confirmed partial response was obtained in three out of seven patients who had bidimensionally measurable disease. Toxicity was manageable. Our study provides further support to the concept of combined antimicrotubule therapy for metastatic harmonoresistant prostate cancer, promoting the exploration of new regimens containing antimicrotubule agents in addition to mitoxantrone-prednisone.

show abstract

Randomized study of vinorelbine and cisplatin versus vindesine and cisplatin versus vinorelbine alone in advanced non-small-cell lung cancer: results of a European multicenter trial including 612 patients.

Abstract: Since our results have demonstrated that NVB-P yields a longer survival duration and a higher response rate than VDS-P or NVB alone, with acceptable toxicity, this combination should be considered a relevant regimen in advanced NSCLC.

Cited by 759 publications

References 20 publications

Fractionated administration of irinotecan and cisplatin for treatment of non-small-cell lung cancer: a phase II study of Okayama Lung Cancer Study Group

Fractionated administration of irinotecan and cisplatin for treatment of non-small-cell lung cancer: a phase II study of Okayama Lung Cancer Study Group

The novel and effective nonplatinum, nontaxane combination of gemcitabine and vinorelbine in advanced nonsmall cell lung carcinoma

Mitoxantrone, vinorelbine and prednisone (MVD) in the treatment of metastatic hormonoresistant prostate cancer — a phase II trial

Contact Info

Product

Resources

About