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 ALC  Vol.3 No.1 , March 2014
Feasibility Study for Biweekly Administration of Cisplatin plus Vinorelbine as Adjuvant-Chemotherapy for Completely Resected Non-Small Cell Lung Cancer Patients in a Japanese Population
Abstract: Purpose: To evaluate the feasibility of biweekly administration of cisplatin and vinorelbine as adjuvant chemotherapy for patients with completely resected non-small cell lung cancer (NSCLC). Patients and Methods: This was a single-arm, single-institutional study. Patients with completely resected NSCLC (p-Stage IB-IIIA) with no previous chemotherapy or radiotherapy were eligible. Simon’s optimal two-stage design was applied. Both cisplatin (50 mg/m2) and vinorelbine (25 mg/m2) were given on days 1 and 15, every 28 days. The primary endpoint of this study was the feasibility of this combination in the four cycles of treatment. Results: Twenty patients (19 lobectomies and 1 pneumonectomy) were enrolled in this study. 10 (50%) of patients had grade 3/4 neutropenia, and 3 (15%) had grade 3/4 anemia. Severe non-hematologic toxicities were uncommon in this series. No treatment-related death was encountered. 18 (90%) patients completed the planned 4 cycles of chemotherapy. The median intensity was 24.3 (range 18.1 to 25) mg/m2/week with an average of 23.6 (21 - 25) mg/m2/week cisplatin and 12.5 (range 10 to 12.5) mg/m2/week with an average of 12.3 (10 - 12.5) mg/m2/week vinorelbine. The median relative dose intensity of cisplatin was 97.5% (range 72.5% to 100%) with an average of 94.6% (72.5% - 100%) and that of vinorelbine was 100% (range 80% to 100%) with an average of 97.8% (80% - 100%). Conclusion: This regimen is feasible in the treatment of patients with completely resected NSCLC. A phase III trial is warranted to assess the efficacy of this regimen at promoting survival and preventing recurrence.
Cite this paper: Tsukamoto, S. , Yamazaki, K. , Mori, R. , Katsura, M. , Kouso, H. , Kawano, D. , Ushijima, C. and Takeo, S. (2014) Feasibility Study for Biweekly Administration of Cisplatin plus Vinorelbine as Adjuvant-Chemotherapy for Completely Resected Non-Small Cell Lung Cancer Patients in a Japanese Population. Advances in Lung Cancer, 3, 1-9. doi: 10.4236/alc.2014.31001.
References

[1]   Jemal, A., Siegel, R., Ward, E., Hao, Y., Xu, J., Murray, T. and Thun, M.J. (2008) Cancer Statistics, 2008. CA: A Cancer Journal for Clinicians, 58, 71-96. http://dx.doi.org/10.3322/CA.2007.0010

[2]   Spira, A. and Ettinger, D.S. (2004) Multidisciplinary Management of Lung Cancer. The New England Journal of Medicine, 350, 379-392. http://dx.doi.org/10.1056/NEJMra035536

[3]   Baldini, E.H., DeCamp Jr., M.M., Katz, M.S., Berman, S.M., Swanson, S.J., Mentzer, S.J., Bueno, R. and Sugarbaker, D.J. (1999) Patterns of Recurrence and Outcome for Patients with Clinical Stage II Non-Small-Cell Lung Cancer. American Journal of Clinical Oncology, 22, 8-14. http://dx.doi.org/10.1097/ 00000421-199902000-00003

[4]   Choi, Y.S., Shim, Y.M., Kim, K. and Kim, J. (2004) Pattern of Recurrence after Curative Resection of Local (Stage I and II) Non-Small Cell Lung Cancer: Difference According to the Histologic Type. Journal of Korean Medical Science, 19, 674-676. http://dx.doi.org/10.3346/jkms.2004.19.5.674

[5]   Westeel, V., Choma, D., Clement, F., Woronoff-Lemsi, M.C., Pugin, J.F., Dubiez, A. and Depierre, A. (2000) Relevance of an Intensive Postoperative Follow-Up after Surgery for Non-Small Cell Lung Cancer. The Annals of Thoracic Surgery, 70, 1185-1190. http://dx.doi.org/10.1016/S0003-4975 (00)01731-8

[6]   Williams, B.A., Sugimura, H., Endo, C., Nichols, F.C., Cassivi, S.D., Allen, M.S., Pairolero, P.C., Deschamps, C. and Yang, P. (2006) Predicting Postrecurrence Survival among Completely Resected Nonsmall-Cell Lung Cancer Patients. The Annals of Thoracic Surgery, 81, 1021-1027.
http://dx.doi.org/10.1016/j.athoracsur.2005.09.020

[7]   Niiranen, A., Niitamo-Korhonen, S., Kouri, M., Assendelft, A., Mattson, K. and Pyrhonen, S. (1992) Adjuvant Chemotherapy after Radical Surgery for Non-Small-Cell Lung Cancer: A Randomized Study. Journal of Clinical Oncology, 10, 1927-1932.

[8]   Scagliotti, G.V., Fossati, R., Torri, V., Crino, L., Giaccone, G., Silvano, G., Martelli, M., Clerici, M., Cognetti, F. and Tonato, M. (2003) Randomized Study of Adjuvant Chemotherapy for Completely Resected Stage I, II, or IIIA Non-Small-Cell Lung Cancer. Journal of the National Cancer Institute, 95, 1453-1461. http://dx.doi.org/10.1093/jnci/djg059

[9]   Tada, H., Tsuchiya, R., Ichinose, Y., Koike, T., Nishizawa, N., Nagai, K. and Kato, H. (2004) A Randomized Trial Comparing Adjuvant Chemotherapy versus Surgery Alone for Completely Resected pN2 Non-Small Cell Lung Cancer (JCOG9304). Lung Cancer, 43, 167-173. http://dx.doi.org/10.1016/ j.lungcan.2003.08.028

[10]   Waller, D., Peake, M.D., Stephens, R.J., Gower, N.H., Milroy, R., Parmar, M.K., Rudd, R.M. and Spiro, S.G. (2004) Chemotherapy for Patients with Non-Small Cell Lung Cancer: The Surgical Setting of the Big Lung Trial. European Journal Cardio-Thoracic Surgery, 26, 173-182. http://dx.doi.org/10.1016/ j.ejcts.2004.03.041

[11]   Arriagada, R., Bergman, B., Dunant, A., Le Chevalier, T., Pignon, J.P. and Vansteenkiste, J. (2004) Cisplatin-Based Adjuvant Chemotherapy in Patients with Completely Resected Non-Small-Cell Lung Cancer. The New England Journal of Medicine, 350, 351-360. http://dx.doi.org/10.1056/NEJ Moa031644

[12]   Douillard, J.Y., Rosell, R., De Lena, M., Carpagnano, F., Ramlau, R., Gonzales-Larriba, J.L., Grodzki, T., Pereira, J.R., Le Groumellec, A., Lorusso, V., Clary, C., Torres, A.J., Dahabreh, J., Souquet, P.J., Astudillo, J., Fournel, P., Artal-Cortes, A., Jassem, J., Koubkova, L., His, P., Riggi, M. and Hurteloup, P. (2006) Adjuvant Vinorelbine plus Cisplatin versus Observation in Patients with Completely Resected Stage IB-IIIA Non-Small-Cell Lung Cancer (Adjuvant Navelbine International Trialist Association [ANITA]): A Randomised Controlled Trial. The Lancet Oncology, 7, 719-727. http://dx.doi.org/10. 1016/S1470-2045(06)70804-X

[13]   Kato, H., Ichinose, Y., Ohta, M., Hata, E., Tsubota, N., Tada, H., Watanabe, Y., Wada, H., Tsuboi, M. and Hamajima, N. (2004) A Randomized Trial of Adjuvant Chemotherapy with Uracil-Tegafur for Adenocarcinoma of the Lung. The New England Journal of Medicine, 350, 1713-1721.
http://dx.doi.org/10.1056/NEJMoa032792

[14]   Winton, T., Livingston, R., Johnson, D., Rigas, J., Johnston, M., Butts, C., Cormier, Y., Goss, G., Inculet, R., Vallieres, E., Fry, W., Bethune, D., Ayoub, J., Ding, K., Seymour, L., Graham, B., Tsao, M.S., Gandara, D., Kesler, K., Demmy, T. and Shepherd, F. (2005) Vinorelbine plus Cisplatin vs. Observation in Resected Non-Small-Cell Lung Cancer. The New England Journal of Medicine, 352, 2589-2597. http://dx.doi.org/10.1056/NEJMoa043623

[15]   Pignon, J.P., Tribodet, H., Scagliotti, G.V., Douillard, J.Y., Shepherd, F.A., Stephens, R.J., Dunant, A., Torri, V., Rosell, R., Seymour, L., Spiro, S.G., Rolland, E., Fossati, R., Aubert, D., Ding, K., Waller, D. and Le Chevalier, T. (2008) Lung Adjuvant Cisplatin Evaluation: A Pooled Analysis by the LACE Collaborative Group. Journal of Clinical Oncology, 26, 3552-3559. http://dx.doi.org/10.1200/JCO. 2007.13.9030

[16]   Pisters, K.M., Evans, W.K., Azzoli, C.G., Kris, M.G., Smith, C.A., Desch, C.E., Somerfield, M.R., Brouwers, M.C., Darling, G., Ellis, P.M., Gaspar, L.E., Pass, H.I., Spigel, D.R., Strawn, J.R., Ung, Y.C. and Shepherd, F.A. (2007) Cancer Care Ontario and American Society of Clinical Oncology Adjuvant Chemotherapy and Adjuvant Radiation Therapy for Stages I-IIIA Resectable Non-Small-Cell Lung Cancer Guideline. Journal of Clinical Oncology, 25, 5506-5518. http://dx.doi.org/10.1200/JCO. 2007.14.1226

[17]   Alam, N., Shepherd, F.A., Winton, T., Graham, B., Johnson, D., Livingston, R., Rigas, J., Whitehead, M., Ding, K. and Seymour, L. (2005) Compliance with Post-Operative Adjuvant Chemotherapy in Non-Small Cell Lung Cancer: An Analysis of National Cancer Institute of Canada and Intergroup Trial JBR.10 and a Review of the Literature. Lung Cancer, 47, 385-394. http://dx.doi.org/10.1016/j. lungcan.2004.08.016

[18]   Yamaguchi, M., Takeo, S., Suemitsu, R. and Matsuzawa, H. (2010) Feasibility Study for Biweekly Administration of Cisplatin plus Gemcitabine as Adjuvant-Chemotherapy for Completely Resected Non-Small Cell Lung Cancer. Cancer Chemotherapy and Pharmacology, 66, 107-112.
http://dx.doi.org/10.1007/s00280-009-1139-x

[19]   Simon, R. (1989) Optimal Two-Stage Designs for Phase II Clinical Trials. Controlled Clinical Trials, 10, 1-10. http://dx.doi.org/10.1016/0197-2456(89)90015-9

[20]   Non-Small Cell Lung Cancer Collaborative Group (1995) Chemotherapy in Non-Small Cell Lung Cancer: A MetaAnalysis Using Updated Data on Individual Patients from 52 Randomised Clinical Trials. Non-Small Cell Lung Cancer Collaborative Group. BMJ, 311, 899-909.
http://dx.doi.org/10.1136/bmj.311.7010.899

[21]   Strauss, G.M., Herndon, J.E., Maddaus, M.A., Johnstone, D.W., Johnson, E.A., Watson, D.M., et al. (2004) Randomized Clinical Trial of Adjuvant Chemotherapy with Paclitaxel and Carboplatin Following Resection in Stage IB Non-Small Cell Lung Cancer (NSCLC): Report of Cancer and Leukemia Group B (CALGB) Protocol 9633. Journal of Clinical Oncology, 22, 621s.

[22]   Strauss, G.M., Herndon, J.E.I., Maddaus, M.A., Johnstone, D.W., Johnson, E.A., Watson, D.M., et al. (2006) Adjuvant Chemotherapy in Stage IB Non-Small Cell Lung Cancer (NSCLC): Update of Cancer and Leukimia Croup B (CALGB) protocol 9633. Journal of Clinical Oncology, 24, 365s.

[23]   Ohe, Y., Ohashi, Y., Kubota, K., Tamura, T., Nakagawa, K., Negoro, S., Nishiwaki, Y., Saijo, N., Ariyoshi, Y. and Fukuoka, M. (2007) Randomized Phase III Study of Cisplatin plus Irinotecan versus Carboplatin plus Paclitaxel, Cisplatin plus Gemcitabine, and Cisplatin plus Vinorelbine for Advanced Non-Small-Cell Lung Cancer: Four-Arm Cooperative Study in Japan. Annals of Oncology, 18, 317-323. http://dx.doi.org/10.1093/annonc/mdl377

[24]   Lopez-Vivanco, G., Viteri, A., Barcelo, R., Munoz, A., Rubio, I., Mane, J.M. and Fuente, N. (2005) Biweekly Administration of Cisplatin/Gemcitabine in Advanced Nonsmall Cell Lung Cancer. American Journal of Clinical Oncology, 28, 501-507. http://dx.doi.org/10.1097/01.coc.0000170583.42741.cd

 
 
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