Abstract
Background. This study was designed to evaluate the feasibility and efficiency of giving cisplatin, etoposide, and OK432 concurrently with conventional radiotherapy (RTx) for patient's with inoperable stage III, based on the TNM classification according to the International Union against Cancer staging system for lung cancer (1987) non-small cell lung cancer (NSCLC).
Methods. From January 1992 to December 1994,31 patients with cytologically or histologically confirmed stage III NSCLC were treated with RTx, to a total dose of 56–64 Gy, with concurrent daily oral administration of etoposide (25mg) and cisplatin (20mg) for 5 days during the third or fourth week from the start of RTx. The subcutaneous injection of 1 or 2 KE of OK-432, three times a week, for the duration of radiotherapy also started from the beginning of RTx.
Results. The number of eligible patients was 29 (26 men and 3 women). Their mean age was 66 years (range, 55–77 years). Six patients had an Eastern Cooperative Oncology Group performance status (PS) of 0; 15, 1; 8; 2. Three were stage IIIA, and 26, stage ITIB. Histologically, 2 had adenocarcinoma, 23, squamous cell carcinoma, and 4, large cell carcinoma. In 27 of the 29 patients, the RTx schedule was completed. There were no treatment-related deaths. Grade 4 toxicity (according to World Health Organisation criteria) leukopenia (700/μl was observed in 1 patient. The response rate was 79% and the median survival was 17 months. Survival rates at 1, 2 and 3 years were 62%, 31%, and 21%, respectively. The local failure rate was 51%.
Conclusion. The combination of cisplatin, etoposide, and K-432, given concurrently with conventional RTx is feasible and effective for inoperable stage III NSCLC.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
References
Perez CA, Bauer M, Edelstein S, et al. (1986) Impact of tumor control on survival in carcinoma of the lung treated with irradiation. Int J Radiat Oncol Biol Phys 12:539–547
Curran WJ, Stafford PM (1990) Lack of apparent difference in outcome between clinically stage IIIA and IIIB non-small-cell lung cancer treated with radiation therapy. J Clin Oncol 8:409–415
Cox JD, Azarnia N, Byhardt RW, et al. (1990) A randomized phase I/11 trial of hyperfractionated radiation therapy with total dose of 60.0 to 79.2 Gy: Possible survival benefit with ?69.6 Gy in favorable patients with Radiation Therapy Oncology Group stage III non-small-cell lung carcinoma: Report of Radiation Therapy Oncology Group 83-11. J Clin Oncol 8:1543–1555
Byhardt RW, Pajak TF, Emami B, et al. (1993) A phase I/II study to evaluate accelerated fractionation via concomitant boost for squamous, adeno, and large cell carcinoma of the lung: Report of Radiation Therapy Oncology Group 84-07. Int J Radiat Oncol Biol Phys 26:459–468
Dillman RO, Seagren SL, Propert KJ, et al. (1990) A randomized trial of induction chemotherapy plus high-dose radiation versus radiation alone in stage III non-small-cell lung cancer. N Engl J Med 323:940–945
Schaake-Koning C, Bogaert Wvd, Dalesio O, et al. (1992) Effect of concomitant cisplatin and radiotherapy on inoperable non-smallcell lung cancer. N Engl J Med 326:524–530
Wolf M, Hans K, Becker H, et al. (1994) Radiotherapy alone versus chemotherapy with ifosfamide/vindesine followed by radiotherapy in unresectable locally advanced non-small cell lung cancer. Semin Oncol 21:42–47
Jeremic B, Shibamoto Y, Acimovic L, Milisavljvic S (1996) Hyperfractionated radiation therapy with or without concurrent low-dose daily carboplatin/etoposide for stage III non-small-cell lung cancer: A randomized study. J Clin Oncol 14:1065–1070
Withers HR, Taylor JMG, Maciejewski B. (1988) The hazard of accelerated tumor clonogen repopulation during radiotherapy. Acta Oncol 27:131–146
Abe Y, Kenton LA, Urano M, et al. (1991) The accelerated repopulation of a murine fibrosarcoma, FSA-11, during the fractionated irradiation and the linear-quadratic model. Int J Radiat Oncol Biol Phys 21:1529–1534
Kaplan EL, Meier P (1958) Nonparametric estimation from incomplete observations. J Am Stat Assoc 53:457–481
Bedini AV, Tavecchio L, Milani F, et al. (1991) Prolonged venous infusion of cisplatin and concurrent radiation therapy for lung carcinoma. Cancer 67:357–362
Gandara DR, Valone FH, Perez EA, et al. (1991) Rapidly alternating radiotherapy and high dose cisplatin chemotherapy in stage IIIB non-small cell lung cancer: Results of a phase I/II study. Int J Radiat Oncol Biol Phys 20:1047–1052
Alberto P, Mirimanoff RO, Mermillod B, et al. (1995) Rapidly alternating combination of cisplatin-based chemotherapy and hyperfractionated accelerated radiotherapy in split course for stage IIIA and stage IIIB non-small cell lung cancer: Results of a phase I-II study by the GOTHA group. Group d'Oncologie Thoracique des Regions Alpines. Eur J Cancer 31A:342–348
Furuse K, Kubota K, Kawahara M, et al. (1995) Phase II study of concurrent radiotherapy and chemotherapy for unresectable stage III non-small-cell lung cancer. Southern Osaka Lung Cancer Study Group. J Clin Oncol 13:869–875
Lee IS, Scott C, Komaki R, et al. (1996) Concurrent chemoradiation therapy with oral etoposide and cisplatin for locally advanced inoperable non-small-cell lung cancer: Radiation Therapy Oncology Group Protocol 91-06. J Clin Oncol 14:1055–1064
Withers HR, Thames HD, Peters LJ (1983) A new isoeffect curve for change in dose per fractionation. Radiother Oncol 1:187–191
Saunders MI, Dische S. (1990) Continuous, hyperfractionated, accelerated radiotherapy (CHART) in non-small cell carcinoma of the bronchus. Int J Radiat Oncol Biol Phys 19:1211–1215
Saunders MJ, Dische S, Grosch EJ, et al. (1991) Experience with CHART. Int J Radiat Oncol Biol Phys 21:871–878
Saunders MI, Dische S, Barrett A, et al. (1996) Randomised multicentre trials of CHART vs conventional radiotherapy in head and neck and non-small cell lung cancer. Br J Cancer 73:1455–1462
Peters LJ, Ang KK, Thames HD. (1988) Accelerated fractionation in the radiation treatment of head and neck cancer. A critical comparison of different strategies. Acta Oncol 27:185–194
Ang KK, Peters LJ, Weber RS, et al. (1990) Concomitant boost radiotherapy schedules in the treatment of carcinoma of the oropharynx and nasopharynx. Int J Radiat Oncol Biol Phys 19:1339–1345
Shaw EG, McGinnis WL, Jett JR, et al. (1993) Pilot study of accelerated hyperfractionated thoracic radiation therapy plus concomitant etoposide and cisplatin chemotherapy in patients with unresectable stage III non-small-cell carcinoma of the lung. J Natl Cancer Inst 85:321–323
Kurishita A, Katoh H, Uehara Y, et al. (1991) Post-irradiation treatment with OK432 can prevent radiation-induced bone marrow death. Int J Radiat Biol 59:711–716
Joshima H, Ohara H, Aoki Y. (1992) The effect of OK-432 upon erythropoietic recovery in sub-lethally irradiated mice: A preliminary report. J Radiat Res 33:290–300
Author information
Authors and Affiliations
About this article
Cite this article
Mariya, Y., Aoki, M., Abe, Y. et al. A phase II study of cisplatin, oral administration of etoposide, OK-432 and radiation therapy for inoperable stage III non-small cell lung cancer. Int J Clin Oncol 3, 365–369 (1998). https://doi.org/10.1007/BF00539214
Received:
Accepted:
Issue Date:
DOI: https://doi.org/10.1007/BF00539214