Limited (LTD) Stage Small Cell Lung Cancer (SCLC) treated with concurrent BID chest radiotherapy...
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153 561 RANDOMIZED STUDY OF ADJWANT CHEMOTHERAPY USING UFT AFTER SURGERY OF NON-SMALL CELL LUNG CANCER Y. Hay&a, C. Konaka and the Research Group for Post- surgical Adjuvant Chemotherapy in the Tokyo Area A randomized study was designed to assess the effe- ctiveness of postsurgical maintenance adjuvant chemo- therapy in non-small cell lung cancer using UFT at the Research Group in the Tokyo Area. A total of 338 cases were registered at 29 institutes from September, 1986 to August, 1989. Cases were divided into 2 groups. Group A; CDDI’(80mg/m*) and VDS (3mg/m2) were admini- stered after surgery. Group B; UFT (250mg/m2/day) was administered orally for 2 years after the same chemo- therapy as Group A. There were 140 eligible cases in Group A and 141 in Group B. There were no significant differences in patient characteristics in the two groups. Survival was compared between the 2 groups according to p stage, T and N factor, curativity and histologic type. There was no difference in overall 4-year survival in 2 groups, however, overall 4-year disease free survival was 54.5% in Group A and 65.5% in Group B, showing a statistical significant diffe- rence. In overall survival, better results were obta- ined in stage la and absolutely curatively resected cases of Group B than Group A, showing a statistical significant difference (P(O.0779 and 0.0662). In over- all 4-year disease free survival, better results were obtained in T2 and absolutely curatively resected cases of Group B, showing a statistical significant difference (P<O.O206 and 0.0297). There was no statis- tical difference between stage II and III cases or according to N factor value and/or histologic type. 569 CARBOPlATlN AND ETOPOSIDE (CM) FOLLOWED BY VlNCRISTINE, DOXORUBICIN AND CYCLOPHOSPNAMIDE (VAC) COMBINED WITH RADIOTHERAPY (RI) IN LlMfTED SMALL CELL LUNG CANCER (SCLC). A PHASE II STUDY. K.Lllc.oo. V.Nlkkmwn. LHelle. R.Huovhte”. M.Jakobno”. M.J6rvl”en. P. Karnani AOiala. S.Palohelmo. R.Salml. E-R.Salomaa. M.Vlren Flnlung Study Group, Fin- land. The actlvlty of two alter”Wlng chemoth4mpy combln4Uonr, CarE and VAC, was studled In llmlted BCLC. AI pta were glwn RT. AJbagetJtw 66 prewfoualy untreated pts (mean age of 62 yw#a and Zubfod ~2) e1$4red the study between April 1969 and October 1996. The don of Car 466 mg/m based o” phase I study by Liippo a aI. (Ca”wr Chemother Phamucol27:229,1990). CarE was glw” Ix on day 1 and E 166 “tg/m’ lx on day4 l-3 every 26 daya for two courses. RT to the prh”ary tumor a”d “wdlaatl”um (66 GY/ 26 fmctlo”~ wIthout rest interval) star- RT ptl recefwd four course4 of VAC on day 1 every 21 days four timer or u”tll proemrion. Cerebral Imdlatfon (36 Gv) was glwn to pts with CR after complaion of the chemotherapy. Ahqpther 42 pts have wmphted the whole reglmsn. The treatment war inter- rupted In 26 pa: 6 pts had pmgresslw disease, 6 pta refused. 9 died and one had sever* thro”lbocytope”la. RESPONSE E+PR (%) after 2CarE +RT + 4VAC 14/a 2w64 14/42 (a) (31) (W 47161 61/64 31142 0 W) (73) ModIan sutvlval tlnn for all pta w.. 14.0 “tths. Sutvlv8l rates for 6, 12 and 16 mth~ww~61%,34%a”d13%,ms~u4lwl Th. fraqum-uy of lwcqm~la (grada 3.4, WH b ) during WrE was 6 % and during VAC 66 %q and Uut of thro”tbocytq~la 11% and 10 %, r~p4ctl~ly. There were flw WeMmo”t r&ted daMha, all of M durl”g VAC. Grada 3-4 nau4ea and vontltl~ occured In 30 % of pta equally during CarE and VAC courses. we cotlclti that the watme”t of SCLC with altomatIng chemotherapy combi- “Won, u8.d h the pms.“t study dld not -strata .“y supwlorlty In survival wef the wquwatlal che”tothanpy. The frequency of hematokqlc4l toxlclty was consfder~bla. 568 RAPIDLY ALTERNATING RADIOTHERAPY AND HIGH DOSE CISPLATIN IN STAGE Ill NON-SMALL CELL LUNG CANCER (NSCLC): RESULTS OF A PILOT STUDY. DR Gandara. FH Valone, EA Perez. AB Deisseroth. M Roach, DK Ahn, T Phillips. Northern California Oncology Group (NCOG). Alternating radiotherapy (RT) and chemotherapy increases tumor curs rates in some animal models compared to sequential use of these modalities and results in reduced normal tissue damage compared to concurrent use. To test this concept in NSCLC, patients (pts) with predominantly stage IIIB disease were treated on a NCOG pilot study of alternating RT and high dose cisplatin. RT consisted of 6000 cGy delivered in three separate 10 day courses of 200 ffiytfractionlday during weeks 1 and 2, 5 and 6. and 9 and 10. Cisplatin lOO/mglm2 in 3% saline was given on weeks 3 and 4, 7 and 6, 11 and 12, and 15 and 16. Median age 59 (40-70). stage IIIA 11118: 6/23. Results are reported in 29 pts with > 1 year of follow up. The response rate in 26 eligible pts is 71% (20/26) with six complete responses and 14 partial responses. Feasibility of this approach is demonstrated by 25126 pts completing RT and a median of 2.5 courses of chemotherapy administered. Median survival time (MST) is 25 months (range 2- 46+ months). MST in Stage IIIB is 11.2 mos. One and two year survival rates are 61% (17/26) and 32% (g/26), respectively. Hematologic, renal, and radiation-related toxicities were significant but manageable. We conclude that rapid alternation of RT and a high dose intensity cisplatin regimen is feasible in Stage Ill NSCLC, with a high response rats and acceptable toxicity. The long-term impact on local control and survival remains unclear, although survival data are encouraging in this poor prognosis population. Further studies of this concept ara warranted. 570 Comparative Phase II Study of CAV-PVP Hybrid(HY) Regimen and CAV-PVP Sequential(SE) Reqimen in Patients with Small Cell Lunq Cancer(SCLC) Hiroshi UEOKA, Taisuke OHNOSHI, Shunkichi HIRAKI, Haruhito KAMEI, Tadashi MAEDA and Ikuro KIMURA Department of Medicine, Okayama University Medical School, Dkayama 700, Japan From November 1987, 92 patients were randomly allocated to receive either HY or SE. consisted of CAV (cyclophosphamide HY regimen 700mg/m2, adriamycin 30mg/m2, vincristine 1.4mg/m2) on day 1 and PVP (cisplatin 60mg/m2 and etoposide lOOmg/m2 x 2 days) on day 8, and repeated up to 6 cycles at 4- week interval. In SE regimen, CAV was given on days 1 & 8 for the initial 3 cycles, followed by 3 cycles of PVP on days 1 & 8. Patients with LD received chest RT at a dose of 5OGy after achieving maximal tumor response and PC1 of 3OGy was delivered for CR patients. Results were the following: Hybrid Sequential LD ED LD ED No. evaluated 21 22 16 No. CR(%) 13(62) 3(I4) ;;(58) 4(25) CR+PR(%) 20(95) 20(91) 19(100) 12(75) MST(months) 19.7 12.3 24.4 13.3 Hematologic toxicity was the major dose-limiting toxicity, but it was well-tolerated for both groups. These results indicate that both regimens are equally effective for SCLC.
Transcript of Limited (LTD) Stage Small Cell Lung Cancer (SCLC) treated with concurrent BID chest radiotherapy...
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RANDOMIZED STUDY OF ADJWANT CHEMOTHERAPY USING UFT AFTER SURGERY OF NON-SMALL CELL LUNG CANCER Y. Hay&a, C. Konaka and the Research Group for Post- surgical Adjuvant Chemotherapy in the Tokyo Area
A randomized study was designed to assess the effe- ctiveness of postsurgical maintenance adjuvant chemo- therapy in non-small cell lung cancer using UFT at the
Research Group in the Tokyo Area. A total of 338 cases were registered at 29 institutes from September, 1986 to August, 1989. Cases were divided into 2 groups. Group A; CDDI’ (80mg/m*) and VDS (3mg/m2) were admini- stered after surgery. Group B; UFT (250mg/m2/day) was administered orally for 2 years after the same chemo- therapy as Group A. There were 140 eligible cases in Group A and 141 in Group B. There were no significant differences in patient characteristics in the two groups. Survival was compared between the 2 groups according to p stage, T and N factor, curativity and histologic type. There was no difference in overall 4-year survival in 2 groups, however, overall 4-year disease free survival was 54.5% in Group A and 65.5% in Group B, showing a statistical significant diffe- rence. In overall survival, better results were obta- ined in stage la and absolutely curatively resected cases of Group B than Group A, showing a statistical significant difference (P(O.0779 and 0.0662). In over- all 4-year disease free survival, better results were obtained in T2 and absolutely curatively resected cases of Group B, showing a statistical significant difference (P<O.O206 and 0.0297). There was no statis- tical difference between stage II and III cases or according to N factor value and/or histologic type.
569
CARBOPlATlN AND ETOPOSIDE (CM) FOLLOWED BY VlNCRISTINE, DOXORUBICIN AND CYCLOPHOSPNAMIDE (VAC) COMBINED WITH RADIOTHERAPY (RI) IN LlMfTED SMALL CELL LUNG CANCER (SCLC). A PHASE II STUDY.
K.Lllc.oo. V.Nlkkmwn. LHelle. R.Huovhte”. M.Jakobno”. M.J6rvl”en. P. Karnani AOiala. S.Palohelmo. R.Salml. E-R.Salomaa. M.Vlren Flnlung Study Group, Fin- land.
The actlvlty of two alter”Wlng chemoth4mpy combln4Uonr, CarE and VAC, was studled In llmlted BCLC. AI pta were glwn RT. AJbagetJtw 66 prewfoualy untreated pts (mean age of 62 yw#a and Zubfod ~2) e1$4red the study between April 1969 and October 1996. The don of Car 466 mg/m based o” phase I study by Liippo a aI. (Ca”wr Chemother Phamucol27:229,1990). CarE was glw” Ix on day 1 and E 166 “tg/m’ lx on day4 l-3 every 26 daya for two courses. RT to the prh”ary tumor a”d “wdlaatl”um (66 GY/ 26 fmctlo”~ wIthout rest interval) star-
RT ptl recefwd four course4 of VAC on day 1 every 21 days four timer
or u”tll proemrion. Cerebral Imdlatfon (36 Gv) was glwn to pts with CR after complaion of the chemotherapy.
Ahqpther 42 pts have wmphted the whole reglmsn. The treatment war inter- rupted In 26 pa: 6 pts had pmgresslw disease, 6 pta refused. 9 died and one had sever* thro”lbocytope”la.
RESPONSE
E+PR (%)
after 2CarE +RT + 4VAC 14/a 2w64 14/42 (a) (31) (W
47161 61/64 31142 0 W) (73)
ModIan sutvlval tlnn for all pta w.. 14.0 “tths. Sutvlv8l rates for 6, 12 and 16 mth~ww~61%,34%a”d13%,ms~u4lwl Th. fraqum-uy of lwcqm~la (grada 3.4, WH b ) during WrE was 6 % and during VAC 66 %q and Uut of thro”tbocytq~la 11% and 10 %, r~p4ctl~ly. There were flw WeMmo”t r&ted daMha, all of M durl”g VAC. Grada 3-4 nau4ea and vontltl~ occured In 30 % of pta equally during CarE and VAC courses.
we cotlclti that the watme”t of SCLC with altomatIng chemotherapy combi- “Won, u8.d h the pms.“t study dld not -strata .“y supwlorlty In survival wef the wquwatlal che”tothanpy. The frequency of hematokqlc4l toxlclty was consfder~bla.
568
RAPIDLY ALTERNATING RADIOTHERAPY AND HIGH DOSE CISPLATIN IN STAGE Ill NON-SMALL CELL LUNG CANCER (NSCLC): RESULTS OF
A PILOT STUDY. DR Gandara. FH Valone, EA Perez. AB Deisseroth. M Roach, DK Ahn, T Phillips. Northern California Oncology Group (NCOG).
Alternating radiotherapy (RT) and chemotherapy increases
tumor curs rates in some animal models compared to sequential use of these modalities and results in reduced normal tissue damage
compared to concurrent use. To test this concept in NSCLC, patients (pts) with predominantly stage IIIB disease were treated
on a NCOG pilot study of alternating RT and high dose cisplatin. RT
consisted of 6000 cGy delivered in three separate 10 day courses
of 200 ffiytfractionlday during weeks 1 and 2, 5 and 6. and 9 and 10. Cisplatin lOO/mglm2 in 3% saline was given on weeks 3 and
4, 7 and 6, 11 and 12, and 15 and 16. Median age 59 (40-70). stage IIIA 11118: 6/23. Results are reported in 29 pts with > 1
year of follow up. The response rate in 26 eligible pts is 71%
(20/26) with six complete responses and 14 partial responses.
Feasibility of this approach is demonstrated by 25126 pts completing RT and a median of 2.5 courses of chemotherapy
administered. Median survival time (MST) is 25 months (range 2- 46+ months). MST in Stage IIIB is 11.2 mos. One and two year survival rates are 61% (17/26) and 32% (g/26), respectively.
Hematologic, renal, and radiation-related toxicities were
significant but manageable. We conclude that rapid alternation of RT and a high dose
intensity cisplatin regimen is feasible in Stage Ill NSCLC, with a
high response rats and acceptable toxicity. The long-term impact
on local control and survival remains unclear, although survival data are encouraging in this poor prognosis population. Further
studies of this concept ara warranted.
570
Comparative Phase II Study of CAV-PVP Hybrid(HY) Regimen and CAV-PVP Sequential(SE) Reqimen in Patients with Small Cell Lunq Cancer(SCLC)
Hiroshi UEOKA, Taisuke OHNOSHI, Shunkichi HIRAKI, Haruhito KAMEI, Tadashi MAEDA and Ikuro KIMURA Department of Medicine, Okayama University Medical School, Dkayama 700, Japan
From November 1987, 92 patients were randomly allocated to receive either HY or SE. consisted of CAV (cyclophosphamide
HY regimen 700mg/m2,
adriamycin 30mg/m2, vincristine 1.4mg/m2) on day 1 and PVP (cisplatin 60mg/m2 and etoposide lOOmg/m2 x 2 days) on day 8, and repeated up to 6 cycles at 4- week interval. In SE regimen, CAV was given on days 1 & 8 for the initial 3 cycles, followed by 3 cycles of PVP on days 1 & 8. Patients with LD received chest RT at a dose of 5OGy after achieving maximal tumor response and PC1 of 3OGy was delivered for CR patients. Results were the following:
Hybrid Sequential LD ED LD ED
No. evaluated 21 22 16 No. CR(%) 13(62) 3(I4) ;;(58) 4(25)
CR+PR(%) 20(95) 20(91) 19(100) 12(75) MST(months) 19.7 12.3 24.4 13.3
Hematologic toxicity was the major dose-limiting toxicity, but it was well-tolerated for both groups. These results indicate that both regimens are equally effective for SCLC.
