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P-599 Gefitinib(Iressa) as first-line therapy in advanced non-small lung cancer
$276
Posters~Non-small ceil lung cancer- Early disease (I-IlIA)
phase II avaluat]on of osaliplat]n plus vinorelbine in advanced NSCLC. To investigate safaty and efficeoy of oxaliplalJn plus vinerelbine in advanced NSCLC Methods: Titrty-four NSCLC chomo-nawe patients hospitalized at our department (23 men. 11 women, median age 61. ECOG PS 0 1/'2 26/8) entered the study, including 21 with stage IV disease and 18. with adenocarcinoma VInorelbine 25mg/m 2 was given as a 5-10min intravenous infus4on on days 1 and 8. and oxaliplatin was dilated in 500ml of 5% glucose solution and administered in an intravenous infusion on day 1 The regimen was repeated avery 3 weeks The efficacy was evaluated after avery two cycles of chemotherapy and survival and tmdcity were followed up Results: A median of 3 cycles per patients was given Of the 34 patients. objective response rate of 29% was achieved Median overall survival was 10 months and the 1-year survival rate was 41% Hematological and non-homatologicel tmdcitiea were comparatively low. without grade 3/'4 of hematological toxicity. Eight patients experienced grade 1 neurosensory toxlaty. Conclusions: OxaliplatinJvinorelbine doublet is a safe and active regimen for advanced NSCLC.
IP-~
Gsfltlnlb(lrsssa) as first-line therapy In advanced non-small lung cancsr
M. Zimmermann I . F. Lutit I . A. Zouhair 2. J. Bauer ~. S. Loyvraz I . R. Stupp I . I Muitid/scip/inary Oncology Center, University of Lausanne Hospita/'s, Lausanne, Switzerland, 2RadtatJon Medicine Center, Umvers~ty of Lausanne Hosptals, Lausanne, Sv,,Ttzerland
Background: Plat]numJJased chemotherapy remains the mainstay for the treatment of unresectablo NSCLC. However. median survival oftitrd generation regimens remain disappointingly short (8-10 months) despite reported high response rates of 20% to over 40% in some phase II tnals. Standard chemotherapy regimens require intravenous access, and are associated with substantial toxicity. Gofit]nlb has shown some e f f e t e / in patients who failed prior plat]numJJased chemotherapy, and offers the advantage of oral administTation, and a good safety profile requiring only minimal clinical surveillance it may be a suitable tTeatment even for patients with a impaired performance status and palJents unable to tolerate cytotosie chemotherapy We administered gefilJnib (Iressa) to patients as first4ine therapy for metastatic NSCLC Methods and Patients: Twenty-two patients (10 males. 12 females) with metastatic NSCLC and who have not received pnor chemotherapy received gohtinib 250mg/d as frst4ine treatment. Two groups of patients were considered for this analysis. Patients unfit to be considered for chemotherapy. and patients in principle eligible for primary clsplat]nbased chemotherapy, for whom chemotherapy was deforTed until tumor progression. Median age was 64 years. ECOG performance score was 0-1 in 45% (10/'22). 2-3 in 36% (8/22) and not recorded in 18% (4/'22). They were 16 adenocarcinomas (inctuclng 3 with BAC foaturas). 2 squamous cell ca~nomas. 2 large cell carcinomas and two NSCLC without further specificetion Results: Mild to moderate skin toxicity occurred in the majority of patients In 1 patient gefitinib was discontinued due to grade 3 diarrhea At disease progression, cytotoxic chemotherapy was given to 5 patients (23%) At a median follow-up of 7 months. 15 patients have died. the estimated median survival is 5 3 months (9,5% c i 1 9 8. 7) In the patients considered unfit for pnmary chemotherapy median survival was only 3 4 months (9,5% c i 1 ,5 8.). while in the others median survival has net been roached. Out of ten elderly patients 3 patients survived for over 15 months. Conclusions: Gefit]nib monetherapy was well tolerated and allows for s~mple outpatient adminislzat]on with minimal ctinical survodlanee. For patients with adequate performance status and organ function capable to receive platinum based chemotherapy, primary therapy with geftinib allows for at least comparable overall s u ~ v a l than initial cytotoxie therapy. The benefit of gofitinib therapy for patients in poor general condition chemotherapy is limited, however e0¢clusive therapy with gefilinib may be a tTeatment option for selected elderly patients When considering tTeatment for NSCLC. the same selection chtena should be employed whether patients are to receive cytotoxic therapy orfor patients considered for non-oytotoxie antitumor therapy than for any other chemotherapy [ ~
Stage IIIA(N2)-IIIB non small c..~l lung cancer (NSCLC): Short-s¢l~sduls clsplatln and vlnorslblne as Induction ohsmothsrapy
P Zucali ~ R Cavina ~. H Soto Parr'a ~. E Campageoli ~. F De V~ncenzo ~. I. Garassino ~. M. Alloisio ~. L. Balzannl ~. G. Coresoli ~. A. Santoro ~. llst/tuto C#r~co Humamtas, Rozzano, M//an, itaty, ~Aztenda Ospeda/tera Ganl,~a/.c/t, Neslma, Catar~a, Italy
Background: There is net a standard induction treatment for locally advanced NSCLC. A~m of tits study was to avaluato the activity and the influonee on rosoctabll~:y of a short, intens4vo schedule of cisplatin and v~norelbino as induction chemotherapy for patients (pts) with stage IliA(N2) IIIB NSCLC.
Methods: Between 8'01 and 6/64 48 pts with pathological stage IliA(N2) IIIB ware enrolled. Three courses of cisplatin 50 mg/m 2 days 1. 2 and vinorelblne 25 mgim 2 days 1. 3 were given avery three weeks with prophylactic G ~ S F from day 11 to 15 In absence of disease progression, pts were evaluated for resection and underwent surgery and/or radiotherapy (RT) Results: Pts charactedstios were: stage IIINIIIB 15/33. M/F 43/5. PS 0/.1 31/.17 One CR (IliA) and 37 PR (14/.15 IliA. 23/33 IIIB) were observed, for a RR of 79% Twenty-six of 48 pts (54%). of which 13/33 stage IIIB (39%). underwent complete resection with 17/'26 (6,5%) downstoged by chemotherapy; adjuvant RT followed surgery in 9 pts. Twenty two pts wore judged unresoctable; 13 (12 stage IIIB) ware treated with raclcal RT. 9 received palliative therapy. Major tosic~es (grade 3-4) wore: noulzopenia in 40 pts (83%). fobnle neulzopenia in 7 (14%); anemia in 3 (6%). constipation in 4 (8%). nausea/vomiting in 10 (21%). No to)Uc death occurred. W~h a median follow~Jp of 13 months (range 5-35). we observed 3 local and 3 distant failures in completely resectod pts. Median time to progression was 14 months in all pts and 21 months in resected pts Median overall survival (OS) has not been reached yet: 1 -yr OS was 83% Conclusions: The short schedule of cisplalJn and vinerelbine was notab~ effective as induction regimen in tits unfavorable subset ofpts (stage IIIB 69%). with a high RR and resectability rate A longer follow-up is needed to assess the impact of this tTeatment on pattern of relapse and survival
Non-small cell lung c a n c e r Early disease (I-IliA) Non-small cell
lung
Monday, 4 July 2005 ~1]
cancer
-
Early disease (I-IliA) 10:00-17:00
High dose radiation therapy with 3 Gy per fraction In medically Inoperable high dose radiation therapy with 3 G'y per fraction In medically Inoperable stags 1/11non-small call lung cancer
Y. Ahn I . B. Kim 2, D. Lim ~. H. Nam I . D. Oh I . Y. Park I . ~Sungfryunkwan Uruv School ot Medicine, Samsung Medical Center, Seoul, South Korea: 2Dankook University Hospital, C__,heonan,South Korea
Background: Surgery Is the treatment of choice for stage 1/11nonsmall cell lung cancer (NSCLC) High dose radiation therapy (HDRT) is usually considered as an aiterna'dve for these patients with centTalndicelJons to surgery, and the authors of this study have employed HDRT with 3 0 Gy per fraction to reduce the overall treatment duration and cost This study is a retTospective analysis and also reports on our results of using HDRT with 3 0 Gy per fraction for those palJents with stage 1/11NSCLC who ware not fit for surgery Methods: From January lg96 till February 2001.3,5 stage 1/11NSCLC patients ware treated wtth HDRT alone at Samsung Medical Center. Twenty two patients (62.9%) had stage I disease and 13 patients (37.1%) had stage II dseaso. The median age was 73 years (range: 55-64 years) and the maJonty ware male patients (32/35; 91.4%). Squarnous cell carcinoma was the most common Itstologlc type in 23 patients (65.7%). followed by adoneearcinoma in eight (22.9%). The median radiation dose to the primary lesion was 60Gy/20 fractions (range: 54-66Gy) over the median duration of 27 days (range: 23 38. days) Twanty-two patients (62 9%) received the elective imadialJon to the meclastinal lymphatics on an incividual basis The patterns of failure. survival, relapse-frea survival and the significance of the prognostic factors ware analyzed The median follow-up period was 24 months (range: 3 72 months) Results: Eleven palJents developed local in-field failures (31 4%). and 13 palJents had cistant metastases (37 1%) The lung was the most common site of distant metastases and this oocurrod in eight patients (8/13; 61.5%). At the time of the last follow~Jp, eight patients were still alive and 27 patients had died. and nine of those deaths wore in no way related to NSCLC. The median survival ponod and the overall survival rates at 1. 2 . 3 . 4 and 5 years for all patients ware 24.0 months. 77.1%. 48.6%. 31.4%. 22.5% and 11.2%. respectively. The median survival ponod and the overall survival rates at 1. 2 . 3 and 4 years for those patients with stage I and II clsease ware 32 and 15 months. 77.3% and 76 9%. 68. 2% and 15 4%. 45 5% and 7 7%. and 30 4% and 7 7%. respectively The median relapse-free survival period and the relapse-free survival rates at 1. 2. 3. 4 and ,5 years for all palJents were 24 months. 77 1%. 48. 7%. 28 6%. 20 4% and 10 2%. respec0vely Using a univanate analysis, stage I and mediastieal irmadialJon dose were found to be the significent prognostic factors affecting the overall survival, relapse-free survival, and local centTol, wftle the Itstologie type of squarnous cell carcinoma was the marginally significantly prognostic factor for local control. Us4ng a mult]vanate analysis, stage I was the significant prognostic factor favorably affecting the relapse free survival. wills the Itstologlc type of squamous cell carcinoma and immediate post RT response were the s~gnifK:antly prognostic factors for local cenb-ol. Treatment related acute and subacute morbidities were observed in 20 patients (57.1%).
Posters~Non-small ceil lung cancer- Early disease (I-IlIA)
phase II avaluat]on of osaliplat]n plus vinorelbine in advanced NSCLC. To investigate safaty and efficeoy of oxaliplalJn plus vinerelbine in advanced NSCLC Methods: Titrty-four NSCLC chomo-nawe patients hospitalized at our department (23 men. 11 women, median age 61. ECOG PS 0 1/'2 26/8) entered the study, including 21 with stage IV disease and 18. with adenocarcinoma VInorelbine 25mg/m 2 was given as a 5-10min intravenous infus4on on days 1 and 8. and oxaliplatin was dilated in 500ml of 5% glucose solution and administered in an intravenous infusion on day 1 The regimen was repeated avery 3 weeks The efficacy was evaluated after avery two cycles of chemotherapy and survival and tmdcity were followed up Results: A median of 3 cycles per patients was given Of the 34 patients. objective response rate of 29% was achieved Median overall survival was 10 months and the 1-year survival rate was 41% Hematological and non-homatologicel tmdcitiea were comparatively low. without grade 3/'4 of hematological toxicity. Eight patients experienced grade 1 neurosensory toxlaty. Conclusions: OxaliplatinJvinorelbine doublet is a safe and active regimen for advanced NSCLC.
IP-~
Gsfltlnlb(lrsssa) as first-line therapy In advanced non-small lung cancsr
M. Zimmermann I . F. Lutit I . A. Zouhair 2. J. Bauer ~. S. Loyvraz I . R. Stupp I . I Muitid/scip/inary Oncology Center, University of Lausanne Hospita/'s, Lausanne, Switzerland, 2RadtatJon Medicine Center, Umvers~ty of Lausanne Hosptals, Lausanne, Sv,,Ttzerland
Background: Plat]numJJased chemotherapy remains the mainstay for the treatment of unresectablo NSCLC. However. median survival oftitrd generation regimens remain disappointingly short (8-10 months) despite reported high response rates of 20% to over 40% in some phase II tnals. Standard chemotherapy regimens require intravenous access, and are associated with substantial toxicity. Gofit]nlb has shown some e f f e t e / in patients who failed prior plat]numJJased chemotherapy, and offers the advantage of oral administTation, and a good safety profile requiring only minimal clinical surveillance it may be a suitable tTeatment even for patients with a impaired performance status and palJents unable to tolerate cytotosie chemotherapy We administered gefilJnib (Iressa) to patients as first4ine therapy for metastatic NSCLC Methods and Patients: Twenty-two patients (10 males. 12 females) with metastatic NSCLC and who have not received pnor chemotherapy received gohtinib 250mg/d as frst4ine treatment. Two groups of patients were considered for this analysis. Patients unfit to be considered for chemotherapy. and patients in principle eligible for primary clsplat]nbased chemotherapy, for whom chemotherapy was deforTed until tumor progression. Median age was 64 years. ECOG performance score was 0-1 in 45% (10/'22). 2-3 in 36% (8/22) and not recorded in 18% (4/'22). They were 16 adenocarcinomas (inctuclng 3 with BAC foaturas). 2 squamous cell ca~nomas. 2 large cell carcinomas and two NSCLC without further specificetion Results: Mild to moderate skin toxicity occurred in the majority of patients In 1 patient gefitinib was discontinued due to grade 3 diarrhea At disease progression, cytotoxic chemotherapy was given to 5 patients (23%) At a median follow-up of 7 months. 15 patients have died. the estimated median survival is 5 3 months (9,5% c i 1 9 8. 7) In the patients considered unfit for pnmary chemotherapy median survival was only 3 4 months (9,5% c i 1 ,5 8.). while in the others median survival has net been roached. Out of ten elderly patients 3 patients survived for over 15 months. Conclusions: Gefit]nib monetherapy was well tolerated and allows for s~mple outpatient adminislzat]on with minimal ctinical survodlanee. For patients with adequate performance status and organ function capable to receive platinum based chemotherapy, primary therapy with geftinib allows for at least comparable overall s u ~ v a l than initial cytotoxie therapy. The benefit of gofitinib therapy for patients in poor general condition chemotherapy is limited, however e0¢clusive therapy with gefilinib may be a tTeatment option for selected elderly patients When considering tTeatment for NSCLC. the same selection chtena should be employed whether patients are to receive cytotoxic therapy orfor patients considered for non-oytotoxie antitumor therapy than for any other chemotherapy [ ~
Stage IIIA(N2)-IIIB non small c..~l lung cancer (NSCLC): Short-s¢l~sduls clsplatln and vlnorslblne as Induction ohsmothsrapy
P Zucali ~ R Cavina ~. H Soto Parr'a ~. E Campageoli ~. F De V~ncenzo ~. I. Garassino ~. M. Alloisio ~. L. Balzannl ~. G. Coresoli ~. A. Santoro ~. llst/tuto C#r~co Humamtas, Rozzano, M//an, itaty, ~Aztenda Ospeda/tera Ganl,~a/.c/t, Neslma, Catar~a, Italy
Background: There is net a standard induction treatment for locally advanced NSCLC. A~m of tits study was to avaluato the activity and the influonee on rosoctabll~:y of a short, intens4vo schedule of cisplatin and v~norelbino as induction chemotherapy for patients (pts) with stage IliA(N2) IIIB NSCLC.
Methods: Between 8'01 and 6/64 48 pts with pathological stage IliA(N2) IIIB ware enrolled. Three courses of cisplatin 50 mg/m 2 days 1. 2 and vinorelblne 25 mgim 2 days 1. 3 were given avery three weeks with prophylactic G ~ S F from day 11 to 15 In absence of disease progression, pts were evaluated for resection and underwent surgery and/or radiotherapy (RT) Results: Pts charactedstios were: stage IIINIIIB 15/33. M/F 43/5. PS 0/.1 31/.17 One CR (IliA) and 37 PR (14/.15 IliA. 23/33 IIIB) were observed, for a RR of 79% Twenty-six of 48 pts (54%). of which 13/33 stage IIIB (39%). underwent complete resection with 17/'26 (6,5%) downstoged by chemotherapy; adjuvant RT followed surgery in 9 pts. Twenty two pts wore judged unresoctable; 13 (12 stage IIIB) ware treated with raclcal RT. 9 received palliative therapy. Major tosic~es (grade 3-4) wore: noulzopenia in 40 pts (83%). fobnle neulzopenia in 7 (14%); anemia in 3 (6%). constipation in 4 (8%). nausea/vomiting in 10 (21%). No to)Uc death occurred. W~h a median follow~Jp of 13 months (range 5-35). we observed 3 local and 3 distant failures in completely resectod pts. Median time to progression was 14 months in all pts and 21 months in resected pts Median overall survival (OS) has not been reached yet: 1 -yr OS was 83% Conclusions: The short schedule of cisplalJn and vinerelbine was notab~ effective as induction regimen in tits unfavorable subset ofpts (stage IIIB 69%). with a high RR and resectability rate A longer follow-up is needed to assess the impact of this tTeatment on pattern of relapse and survival
Non-small cell lung c a n c e r Early disease (I-IliA) Non-small cell
lung
Monday, 4 July 2005 ~1]
cancer
-
Early disease (I-IliA) 10:00-17:00
High dose radiation therapy with 3 Gy per fraction In medically Inoperable high dose radiation therapy with 3 G'y per fraction In medically Inoperable stags 1/11non-small call lung cancer
Y. Ahn I . B. Kim 2, D. Lim ~. H. Nam I . D. Oh I . Y. Park I . ~Sungfryunkwan Uruv School ot Medicine, Samsung Medical Center, Seoul, South Korea: 2Dankook University Hospital, C__,heonan,South Korea
Background: Surgery Is the treatment of choice for stage 1/11nonsmall cell lung cancer (NSCLC) High dose radiation therapy (HDRT) is usually considered as an aiterna'dve for these patients with centTalndicelJons to surgery, and the authors of this study have employed HDRT with 3 0 Gy per fraction to reduce the overall treatment duration and cost This study is a retTospective analysis and also reports on our results of using HDRT with 3 0 Gy per fraction for those palJents with stage 1/11NSCLC who ware not fit for surgery Methods: From January lg96 till February 2001.3,5 stage 1/11NSCLC patients ware treated wtth HDRT alone at Samsung Medical Center. Twenty two patients (62.9%) had stage I disease and 13 patients (37.1%) had stage II dseaso. The median age was 73 years (range: 55-64 years) and the maJonty ware male patients (32/35; 91.4%). Squarnous cell carcinoma was the most common Itstologlc type in 23 patients (65.7%). followed by adoneearcinoma in eight (22.9%). The median radiation dose to the primary lesion was 60Gy/20 fractions (range: 54-66Gy) over the median duration of 27 days (range: 23 38. days) Twanty-two patients (62 9%) received the elective imadialJon to the meclastinal lymphatics on an incividual basis The patterns of failure. survival, relapse-frea survival and the significance of the prognostic factors ware analyzed The median follow-up period was 24 months (range: 3 72 months) Results: Eleven palJents developed local in-field failures (31 4%). and 13 palJents had cistant metastases (37 1%) The lung was the most common site of distant metastases and this oocurrod in eight patients (8/13; 61.5%). At the time of the last follow~Jp, eight patients were still alive and 27 patients had died. and nine of those deaths wore in no way related to NSCLC. The median survival ponod and the overall survival rates at 1. 2 . 3 . 4 and 5 years for all patients ware 24.0 months. 77.1%. 48.6%. 31.4%. 22.5% and 11.2%. respectively. The median survival ponod and the overall survival rates at 1. 2 . 3 and 4 years for those patients with stage I and II clsease ware 32 and 15 months. 77.3% and 76 9%. 68. 2% and 15 4%. 45 5% and 7 7%. and 30 4% and 7 7%. respectively The median relapse-free survival period and the relapse-free survival rates at 1. 2. 3. 4 and ,5 years for all palJents were 24 months. 77 1%. 48. 7%. 28 6%. 20 4% and 10 2%. respec0vely Using a univanate analysis, stage I and mediastieal irmadialJon dose were found to be the significent prognostic factors affecting the overall survival, relapse-free survival, and local centTol, wftle the Itstologie type of squarnous cell carcinoma was the marginally significantly prognostic factor for local control. Us4ng a mult]vanate analysis, stage I was the significant prognostic factor favorably affecting the relapse free survival. wills the Itstologlc type of squamous cell carcinoma and immediate post RT response were the s~gnifK:antly prognostic factors for local cenb-ol. Treatment related acute and subacute morbidities were observed in 20 patients (57.1%).