Acta Oncologica
ISSN: 0284-186X (Print) 1651-226X (Online) Journal homepage: http://www.tandfonline.com/loi/ionc20
Bestatin in Resected Lung Cancer A randomized clinical trial T. Yasumitsu, S. Ohshima, N. Nakano, Y. Kotake & S. Tominaga To cite this article: T. Yasumitsu, S. Ohshima, N. Nakano, Y. Kotake & S. Tominaga (1990) Bestatin in Resected Lung Cancer A randomized clinical trial, Acta Oncologica, 29:6, 827-831 To link to this article: http://dx.doi.org/10.3109/02841869009093009
Published online: 20 Mar 2010.
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Full Terms & Conditions of access and use can be found at http://www.tandfonline.com/action/journalInformation?journalCode=ionc20 Download by: [70.91.121.189]
Date: 16 February 2016, At: 03:31
Acfa Oncologica 29 (1990) Fasc. 6
FROM THE DEPARTMENT OF SURGERY, OSAKA PREFECTURAL HABIKINO HOSPITAL, OSAKA, AND THE AICHI CANCER CENTER RESEARCH INSTITUTE, NAGOYA, JAPAN
BESTATIN IN RESECTED LUNG CANCER A randomized clinical trial
Downloaded by [70.91.121.189] at 03:31 16 February 2016
T. YASUMITSU,S. OHSHIMA, N. NAKANO,Y. KOTAKEand S. TOMINAGA
Abstract A randomized study with and without bestatin, a new biological
response modifier, was conducted in order to evaluate its survival effect on resected lung cancer. A total of 153 patients (72 with squamous cell carcinoma, 66 with adenocarcinoma, and 15 with other types of cancer) were evaluated. Among the patients with squamous cell carcinoma, the bestatin-treated group had significantly prolonged survival compared to the control group. No significant difference between the two groups was seen in adenocarcinoma. Key words: Lung cancer, bestatin, postoperative, adjuvant therapy, immunotherapy, randomized study.
Chemotherapy and/or radiotherapy corresponding to the histology, stage and operative curability is routinely used as postoperative adjuvant therapy in patients operated on for lung cancer in our department. Bestatin (Ubenimex), a low molecular biological response modifier (l), was added to this therapeutic regimen in a randomized clinical trial. The interim results of this investigation are now reported.
Material and Methods Cases entered this study on the basis of the following criteria: 1) a diagnosis of primary lung cancer based on histology or cytology; 2) no previous treatment; 3) surgical resection; 4) less than 75 years of age; 5 ) no complicating diseases; 6) no double primary cancer. The patients were randomly allocated to either bestatin treatment or no such treatment after surgery by the sealed envelope method. Before randomization, the adenocarcinoma patients were stratified into 4 classes: pathological stage I, I1 or
I11 and those judged as absolutely incurable despite the resection (Fig. 1). The stage I cases were also stratified with regard to treatment with tegafur or not, the stage I1 and 111 cases with regard to M A F (mitomycin+ doxorubicin tegafur) treatment or not, and the absolutely incurable operated cases with regard to M A F treatment o r treatment with cisplatin tegafur (CIS FT). After this stratification the patients were randomized to a bestatin group ( B group) or a control group ( C group) by the sealed envelope method. Tegafur was administered orally with 600-800mg/day for more than 1 year. Cisplatin was administered i.v. with 80 mg/m2 1-2 times. In M A F treatment mitomycin 4 mg and doxorubicin 20 mg were administered i.v. 5 times/week, and tegafur given orally with 600-800mg/day for 9 weeks. This M A F course was followed by a 6-week drug resting interval. A total 3 M A F courses were given. Bestatin (Ubenimex) 3 0 m g orally per day was given for as long period as possible. The squamous cell carcinoma and large cell carcinoma trial design is shown in Fig. 2. The cases were classified in the same way as the adenocarcinomas, and the following stratifications were applied: stage I with or without tegafur; stage 11, stage 111 and the absolutely incurable resected cases with o r without ( C I S + F T ) . All stage 111 and the incurable operated cases received radiotherapy (RT). After classification and stratification, the patients were randomized to a bestatin group or a control group. The
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Presented at the 16th International Congress of Chemotherapy, Jerusalem, Israel, June 1 1- 16, 1989. Accepted for publication 10 January 1990.
827
828
T. YASUMITSU ET AL
Table 1 Patient characteristics. AN eligible cases
No. of patients
Fig. 1. Trial design for adenocarcinoma. FT: tegafur 600 mg p.0. daily ( 3 1 year). CIS: cisplatin 80 mg/m2 i.v. x 1-2. Ubenimex (bestatin): 30 mg p.0. daily ( 31 year). MAF: mitomycin 4 mg i.v. x 5 (biweekly) doxorubicin 20 mg i.v. x 5 (biweekly) + FT 600 mg p.0. daily x 9 weeks, x 3.
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IOperation-I Stratification b[AssignmentJ Stage I
Downloaded by [70.91.121.189] at 03:31 16 February 2016
Stage
ISSN: 0284-186X (Print) 1651-226X (Online) Journal homepage: http://www.tandfonline.com/loi/ionc20
Bestatin in Resected Lung Cancer A randomized clinical trial T. Yasumitsu, S. Ohshima, N. Nakano, Y. Kotake & S. Tominaga To cite this article: T. Yasumitsu, S. Ohshima, N. Nakano, Y. Kotake & S. Tominaga (1990) Bestatin in Resected Lung Cancer A randomized clinical trial, Acta Oncologica, 29:6, 827-831 To link to this article: http://dx.doi.org/10.3109/02841869009093009
Published online: 20 Mar 2010.
Submit your article to this journal
Article views: 43
View related articles
Full Terms & Conditions of access and use can be found at http://www.tandfonline.com/action/journalInformation?journalCode=ionc20 Download by: [70.91.121.189]
Date: 16 February 2016, At: 03:31
Acfa Oncologica 29 (1990) Fasc. 6
FROM THE DEPARTMENT OF SURGERY, OSAKA PREFECTURAL HABIKINO HOSPITAL, OSAKA, AND THE AICHI CANCER CENTER RESEARCH INSTITUTE, NAGOYA, JAPAN
BESTATIN IN RESECTED LUNG CANCER A randomized clinical trial
Downloaded by [70.91.121.189] at 03:31 16 February 2016
T. YASUMITSU,S. OHSHIMA, N. NAKANO,Y. KOTAKEand S. TOMINAGA
Abstract A randomized study with and without bestatin, a new biological
response modifier, was conducted in order to evaluate its survival effect on resected lung cancer. A total of 153 patients (72 with squamous cell carcinoma, 66 with adenocarcinoma, and 15 with other types of cancer) were evaluated. Among the patients with squamous cell carcinoma, the bestatin-treated group had significantly prolonged survival compared to the control group. No significant difference between the two groups was seen in adenocarcinoma. Key words: Lung cancer, bestatin, postoperative, adjuvant therapy, immunotherapy, randomized study.
Chemotherapy and/or radiotherapy corresponding to the histology, stage and operative curability is routinely used as postoperative adjuvant therapy in patients operated on for lung cancer in our department. Bestatin (Ubenimex), a low molecular biological response modifier (l), was added to this therapeutic regimen in a randomized clinical trial. The interim results of this investigation are now reported.
Material and Methods Cases entered this study on the basis of the following criteria: 1) a diagnosis of primary lung cancer based on histology or cytology; 2) no previous treatment; 3) surgical resection; 4) less than 75 years of age; 5 ) no complicating diseases; 6) no double primary cancer. The patients were randomly allocated to either bestatin treatment or no such treatment after surgery by the sealed envelope method. Before randomization, the adenocarcinoma patients were stratified into 4 classes: pathological stage I, I1 or
I11 and those judged as absolutely incurable despite the resection (Fig. 1). The stage I cases were also stratified with regard to treatment with tegafur or not, the stage I1 and 111 cases with regard to M A F (mitomycin+ doxorubicin tegafur) treatment or not, and the absolutely incurable operated cases with regard to M A F treatment o r treatment with cisplatin tegafur (CIS FT). After this stratification the patients were randomized to a bestatin group ( B group) or a control group ( C group) by the sealed envelope method. Tegafur was administered orally with 600-800mg/day for more than 1 year. Cisplatin was administered i.v. with 80 mg/m2 1-2 times. In M A F treatment mitomycin 4 mg and doxorubicin 20 mg were administered i.v. 5 times/week, and tegafur given orally with 600-800mg/day for 9 weeks. This M A F course was followed by a 6-week drug resting interval. A total 3 M A F courses were given. Bestatin (Ubenimex) 3 0 m g orally per day was given for as long period as possible. The squamous cell carcinoma and large cell carcinoma trial design is shown in Fig. 2. The cases were classified in the same way as the adenocarcinomas, and the following stratifications were applied: stage I with or without tegafur; stage 11, stage 111 and the absolutely incurable resected cases with o r without ( C I S + F T ) . All stage 111 and the incurable operated cases received radiotherapy (RT). After classification and stratification, the patients were randomized to a bestatin group or a control group. The
+
+
+
Presented at the 16th International Congress of Chemotherapy, Jerusalem, Israel, June 1 1- 16, 1989. Accepted for publication 10 January 1990.
827
828
T. YASUMITSU ET AL
Table 1 Patient characteristics. AN eligible cases
No. of patients
Fig. 1. Trial design for adenocarcinoma. FT: tegafur 600 mg p.0. daily ( 3 1 year). CIS: cisplatin 80 mg/m2 i.v. x 1-2. Ubenimex (bestatin): 30 mg p.0. daily ( 31 year). MAF: mitomycin 4 mg i.v. x 5 (biweekly) doxorubicin 20 mg i.v. x 5 (biweekly) + FT 600 mg p.0. daily x 9 weeks, x 3.
+
IOperation-I Stratification b[AssignmentJ Stage I
Downloaded by [70.91.121.189] at 03:31 16 February 2016
Stage
