- Email: [email protected]
P-515 Sequential combination chemotherapy for advanced non-small cell lung cancer: Paclitaxel and cisplatin followed by vinorelbine and cisplatin
$252
Posters/Non-smafl ceil lung c a n c e r - Advanced disease (IIIB/IV)
such as leukopenia or thrembocytoperla of grade Ill/IV were observed. The median overall survival was 8. months (range 6 10 months) and meclan time to progression was 4 months (range 3 ,5 months) Conclusion: This protocol (Epidbicln+ C/splat/n+ 5-FU) is an effective and well tolerated regimen for advanoed NSCLC. compare to historical data Pa~oularty its cost benefit ratio is remarkable Because of non serious toxicities, we recommend higher doses of 5-FU in double arm phase II tnals comparing to standard protocols
~
Clinical utility of adenosine trlphoephate-baeed ctlemoesnsltlvlty response assay (ATP-CRA) In non-small cell lung cermer: Preliminary study
B. I~m ~. Y. A l ~ . Y. Noh I . C. Kim 2. J. Lee 2. J. KJm~. E. Ycon ~. H. Leo ~. S. Chol 3. ~Seoa~ V~terans Hos~tal, Sooul, South Korea, 2Korea Cancer
Center Hospttal, South Korea, ~ISU ABXYS Co., Lid, South Korea Background: Selection of optimal agents by laboratory test would in theory allow individualization of cancer tTeatment Objectives of this study were to verify the ~asibility of A T P ~ R A using brenchoscopic biopsy specimens and the accurate prediction of clinical response to chemotherabeutJe agents in NSCLC Methods: Biopsy specimens (,5 8 to 22 9 rag. mean 16 6 rag) were obtained dunng brenchescopy from 59 suspected lung cancer pafients. Tumor cells were isolated by mechanical and eriz'ymat]o clseggregation followed by picol density gradient canthfugat]on. After 48 hours Izeatmont with ant]~:ancer drugs. we evaluated the cell viability by measuring the intracollular ATP levels of drug boated cell and untreated conlzols at peak plasma concanlzation of each drug. The sensitivity defined as a 30% or more reduction of ATP compared to unb-eated conb-ol (p= 0.1026. Fishor's e~act test). Results: The assay results were available within four days Interpretable results were obtained in 84 5% of specimens Nine cases were failed to evaluate due to microbial contaminafion (,5 cases) and less viable cells (4 cases) Clinical outcome were evaluable in 13 patients who were successfully tested The chemotherapy regimen consisted of paclitaxel and cerboplatin as first line therapy The din/col responses were blincly compared with ATP-CRA results The mean coefficient of variation for triplicate ATP measurement was 12 2% The sensitIvity and specificity was 83% and 71%. resgect]voly. The positive predictive value and negative predictive value was 83% and 71%. respectively. The overall clagnostic accuracy was 77% Conclusions: The AlP CRA using the bronchoscopic biopsy specimens has potonfial usefulness as an in vitro chemosensitIvity screening test in NSCLC. The high evaiuabillty rate and observed correlation with tumor response supported the u s e of APTCRA in prospective assay~lirocted thals. This preliminary study, within the limitation of small size of enrolled patients, is ongoing ~2~
Preliminary results of ~ s prospective randomized phase III ~ a l of KROG 03-02 on the Induction chemotherapy In the concurrent chemoradlotherapy for the locally advanced non-small cell lung cancer
S . ~ m . E. Chei . J. Kim . S. Lee . S. K~m . C. Suh . J. Leo . S. Ha . C. Park 3. K. Cho 4. 1Department ot Redtation Ontology, Asan Medtcal Center,
College of Medicine, University of U/san, Seo~, South Korea, 2Deparfmant or Internal Medcine, Asan Medical Center, College or Medicine, University ot U/san, Seoul, South Korea: ~Department ot Therapeutic Radiology, Seoul National Universi~ College of Medicine, Seoul, South Korea, #Research Institute and Hospttal, National Cancer Center, Gyeonggi-clo, South Korea Background: To investigate the role oftbe induction chemotherapy concaming the b-eatmont results and toxic~as in the concurrent chemoradiothorapy (CCRT) for the locally advanced non small cell lung cancer (NSCLC). Mathods: Patients with unresectable and pathologically confirmed Stage III NSCLC were eligible According to the stage and pathologic subgroup. they were randomized into two arms Arm A received two cycles of the induction chemotherapy composed of gom~abine 1000 mg/m ~ (£)1. DS) and clsplal~n 70 m~'m ~ (D1) followed by CCRT with weekly paclitaxel 50 m~m ~ and clsplat]n 20 mg/m 2. Arm B received immediate CCRT without the induction chemotherapy. Radiation therapy performed with bypofract]onated scheme (2 2 Gy/fractJon. once a day) and total irraclated does was 66Gy Irradiated volume encompassed gross tumor plus 1 0 cm margin Results: From May 2003 to May 2064. 63 pal~ents were enrolled Fortyfour patients (Arm A: 23. Arm B: 21) were evaluable whose follow-up period e0¢ceeded 1 month after the end of assigned treatment Median follow-up pededs were 6 months for Arm A and 7 months for Arm B respectively Pafients characteristics including gender, age. weight loss. performance status. pulmonary function and stage were not different between two arms. One year survival rates wore ,58% for Arm A and 63% for Arm B. and wllch showed no stafistical significance yet Co= 0.6667). The compliance of the induction chemotherapy was 96% (22/23 pafients), and these of the CCRT wore 88% for both arms (18/21 patients). The response rate of the induction chemotherapy
was 64% (14/22 pafionts) and these of the CCRT were 83% (15/18 patients) for Arm A and 8.9% (16/18. palJents) for Arm B (p 0 630) Eight pafients (35%) of 23 pafients in Arm A e~pedenced neutrepenia above grade 3 dudng the induction chemotherapy and 1 pafient clod from sepsis CCRT caused nsUtTopenia above grade 3 in 6 palJents of Arm A (29%) and 1 pafient of Arm B (5%) Co 0 038.) RaclalJon pneumonitis above grade 3 developed in 2 palJents of Am1 A (10%) and 1 palJent in Arm B (5%)(p 0 464) and acute asophagitis above grade 3 developed in 7 of Arm A and 5 patients of Arm B Co= 0.495). Conclusions: Both b'eatment schemes showed aoceptable Iznatment corn p/lanes and toxic/ties, but the induction chemothera W developed the higher inodence of severe noub'openia. Treatment outcome showed no statisfical slgeificance yet between the two arms. To evaluate the role of the induction chemotherapy on the survival prolongation in the CCRT for locally advanced NSCLC. more patients and longer follow up are mandatory. Kaywords: Phase III randomized thai. locally-advanced non-smail cell lung cancer, induction chemotherapy, concurrent chemoracictheraby Actmowledgement: This work was supported by 2003 Korean Nafional Cancer Center "Cancer ContToI Program"
[~3]
The efficacy and safety of padsxol (padltaxel) and clsplatln In advanced non-small cell lung Cancer
H. Kim ~, J. Kim 2, H. R y o J , D. Shin 4, C. Kim I , K. Park 2, S. Bae ~, B. Shim ~.
1St Vincent's Hospital, The Catholic University of Korea, Suwon, SouZh Korea, 2Korea Untversrty Medical Center, Seoul, South Korea: 3Daegu Catholic University Hospital, Daegu, SouZh Korea, 4Daegu Fatima Hospital, Daegu, SouZh Korea Background: Paclitaxel & cisplatin combinalJon chemotherapy is one of agents commonly used for non-small call lung cancer We conducted atnal to evaluate the efficacy & safety of Padexol (ne.~ genede of paditaxel produced by Shin Poong Pharm. Co.) in advanced non small call lung cancer. Methods: Pade~ol was given iv for 3 hrs with 175mg/m 2 which was followed by osplatin Iv with 75mg/m2/ Standard premodicat]on including steroid, ant]histamin & H2 blocker for Pad~ol. & hydration /antiomefica for clsplafin was gIven before chemotherapy.The inclusion criteria were pafionts w~h pathologically clagnosed inoperable or metastafic non small call lung cancer with measurable lesions, cherno nerve patients & pafients who fit other standard criteria The chemotherapy was repeated every 3 wks for a total of 6 cycles unless progressed The protocol was approved by IRB of each institutions and informed consent was signed by palJents Results: A total of 40 patients were enrolled from Jan to Nov 2064 The median age was 63years (range 47 74). & there were 32 male & 8. female The performance status was ECOG grade o in 10. 1 in 29 & 2 in 1 There were 20 squomous cell ca. 17 adenoca. & 3 others There palJents were not evaluablo for IT[ analysis (1 developed grade 3 dyspnea after 1st cydo. 1 clod suddenly after full-recovery from 2 na cycle. & 1 was late for 2 nd cycle) Nine patients were not evaiuablo for PP analysis(3 withdrew consent after 3rd cycle. 1 died of massive hemoptysis after 3 r~ cycle. 1 stopped after 3 r~ cycle for grade 3 neuropathy. & 1 developed pneumonia after 2 r~ cycle). A total of 169 cycles were given. Non~omatological grade 3/4 tc0ciclt]as developed in 22.5% of cyoles; nausea 3.6%. myalgia 3.0%. anorexia 2.4%. dyspnea 2.4%. general weakness 1 2%. hyponatremia 1 2%. mucositis 1 2%. nsuropathy 1 2%. & vom~ng 1 2% Hematological grade 3/4 to)dcifies developed in 1g 5% of cycles: nsutTopenia 11 2%. anemia 4 1%. febrile neutTopenia 1 2%. & leucocytobenia 1 2% There was no patient with chemotherapy related death There was no senous hypersensitivity reac~on There were 1 CR & 14 PR with overall response rate of 40 `5%(g`5%C1:24 5 56 6%) by ITI" analysis in 37 patients The overall resgese rate was 48 4%(g`5%CI 30,5 66 3%) by PP analysis in 31 patients. The response duration and survIval data will be presented. Conclusions: Padoxol (paclitaxel) & c~splafin combinafion chemotherapy was very active for advanced nor~smail cell lung cancer with lesser inc~donoe of severe myalgia or hypersensitIvity reaction. [ P ~ 4 ] Impact of thlrO-Ilne =t~emotherapy on long-term =Jrvlvom of advanced non-small ¢l~1 lung cancer (NSCLC) T Kim. S K i m . S P a r k . J Paek. I Choi. D Kim. T Kim. D Heo. YBang. N Kim Seou/National University Hos~tal, Seoul, Soulh Korea
Background: The aim of this study was to evaluate the role of third4ino chemotherapy for advanced non-small cell lung cancer patients who previously received paclitaxel- and gemcitabine~ased combinafion chemotherapy Methods: An analysis was performed on newly diagnosed patients with stage Ills or IV NSCLC who had received either paditaxel (P)- followed by gemcitabine (G)~)ased chemotherapy (P G: group A) or gemcitabinefollowed by paclitaxel~)ased chemotherapy (G P: group B) between January 2000 and October 2004. A total of 198 patients were evaluated. All pafients recaived combination chemotherapy wtth platinum compounds in first4ino Izeatmont. Among 198 patients, 133 patients received third line chemotherapy with gefit]nib monothorapy (38%) or other chemotherapy (62%).
Posters/Non-smafl ceil lung c a n c e r - Advanced disease (IIIB/IV)
such as leukopenia or thrembocytoperla of grade Ill/IV were observed. The median overall survival was 8. months (range 6 10 months) and meclan time to progression was 4 months (range 3 ,5 months) Conclusion: This protocol (Epidbicln+ C/splat/n+ 5-FU) is an effective and well tolerated regimen for advanoed NSCLC. compare to historical data Pa~oularty its cost benefit ratio is remarkable Because of non serious toxicities, we recommend higher doses of 5-FU in double arm phase II tnals comparing to standard protocols
~
Clinical utility of adenosine trlphoephate-baeed ctlemoesnsltlvlty response assay (ATP-CRA) In non-small cell lung cermer: Preliminary study
B. I~m ~. Y. A l ~ . Y. Noh I . C. Kim 2. J. Lee 2. J. KJm~. E. Ycon ~. H. Leo ~. S. Chol 3. ~Seoa~ V~terans Hos~tal, Sooul, South Korea, 2Korea Cancer
Center Hospttal, South Korea, ~ISU ABXYS Co., Lid, South Korea Background: Selection of optimal agents by laboratory test would in theory allow individualization of cancer tTeatment Objectives of this study were to verify the ~asibility of A T P ~ R A using brenchoscopic biopsy specimens and the accurate prediction of clinical response to chemotherabeutJe agents in NSCLC Methods: Biopsy specimens (,5 8 to 22 9 rag. mean 16 6 rag) were obtained dunng brenchescopy from 59 suspected lung cancer pafients. Tumor cells were isolated by mechanical and eriz'ymat]o clseggregation followed by picol density gradient canthfugat]on. After 48 hours Izeatmont with ant]~:ancer drugs. we evaluated the cell viability by measuring the intracollular ATP levels of drug boated cell and untreated conlzols at peak plasma concanlzation of each drug. The sensitivity defined as a 30% or more reduction of ATP compared to unb-eated conb-ol (p= 0.1026. Fishor's e~act test). Results: The assay results were available within four days Interpretable results were obtained in 84 5% of specimens Nine cases were failed to evaluate due to microbial contaminafion (,5 cases) and less viable cells (4 cases) Clinical outcome were evaluable in 13 patients who were successfully tested The chemotherapy regimen consisted of paclitaxel and cerboplatin as first line therapy The din/col responses were blincly compared with ATP-CRA results The mean coefficient of variation for triplicate ATP measurement was 12 2% The sensitIvity and specificity was 83% and 71%. resgect]voly. The positive predictive value and negative predictive value was 83% and 71%. respectively. The overall clagnostic accuracy was 77% Conclusions: The AlP CRA using the bronchoscopic biopsy specimens has potonfial usefulness as an in vitro chemosensitIvity screening test in NSCLC. The high evaiuabillty rate and observed correlation with tumor response supported the u s e of APTCRA in prospective assay~lirocted thals. This preliminary study, within the limitation of small size of enrolled patients, is ongoing ~2~
Preliminary results of ~ s prospective randomized phase III ~ a l of KROG 03-02 on the Induction chemotherapy In the concurrent chemoradlotherapy for the locally advanced non-small cell lung cancer
S . ~ m . E. Chei . J. Kim . S. Lee . S. K~m . C. Suh . J. Leo . S. Ha . C. Park 3. K. Cho 4. 1Department ot Redtation Ontology, Asan Medtcal Center,
College of Medicine, University of U/san, Seo~, South Korea, 2Deparfmant or Internal Medcine, Asan Medical Center, College or Medicine, University ot U/san, Seoul, South Korea: ~Department ot Therapeutic Radiology, Seoul National Universi~ College of Medicine, Seoul, South Korea, #Research Institute and Hospttal, National Cancer Center, Gyeonggi-clo, South Korea Background: To investigate the role oftbe induction chemotherapy concaming the b-eatmont results and toxic~as in the concurrent chemoradiothorapy (CCRT) for the locally advanced non small cell lung cancer (NSCLC). Mathods: Patients with unresectable and pathologically confirmed Stage III NSCLC were eligible According to the stage and pathologic subgroup. they were randomized into two arms Arm A received two cycles of the induction chemotherapy composed of gom~abine 1000 mg/m ~ (£)1. DS) and clsplal~n 70 m~'m ~ (D1) followed by CCRT with weekly paclitaxel 50 m~m ~ and clsplat]n 20 mg/m 2. Arm B received immediate CCRT without the induction chemotherapy. Radiation therapy performed with bypofract]onated scheme (2 2 Gy/fractJon. once a day) and total irraclated does was 66Gy Irradiated volume encompassed gross tumor plus 1 0 cm margin Results: From May 2003 to May 2064. 63 pal~ents were enrolled Fortyfour patients (Arm A: 23. Arm B: 21) were evaluable whose follow-up period e0¢ceeded 1 month after the end of assigned treatment Median follow-up pededs were 6 months for Arm A and 7 months for Arm B respectively Pafients characteristics including gender, age. weight loss. performance status. pulmonary function and stage were not different between two arms. One year survival rates wore ,58% for Arm A and 63% for Arm B. and wllch showed no stafistical significance yet Co= 0.6667). The compliance of the induction chemotherapy was 96% (22/23 pafients), and these of the CCRT wore 88% for both arms (18/21 patients). The response rate of the induction chemotherapy
was 64% (14/22 pafionts) and these of the CCRT were 83% (15/18 patients) for Arm A and 8.9% (16/18. palJents) for Arm B (p 0 630) Eight pafients (35%) of 23 pafients in Arm A e~pedenced neutrepenia above grade 3 dudng the induction chemotherapy and 1 pafient clod from sepsis CCRT caused nsUtTopenia above grade 3 in 6 palJents of Arm A (29%) and 1 pafient of Arm B (5%) Co 0 038.) RaclalJon pneumonitis above grade 3 developed in 2 palJents of Am1 A (10%) and 1 palJent in Arm B (5%)(p 0 464) and acute asophagitis above grade 3 developed in 7 of Arm A and 5 patients of Arm B Co= 0.495). Conclusions: Both b'eatment schemes showed aoceptable Iznatment corn p/lanes and toxic/ties, but the induction chemothera W developed the higher inodence of severe noub'openia. Treatment outcome showed no statisfical slgeificance yet between the two arms. To evaluate the role of the induction chemotherapy on the survival prolongation in the CCRT for locally advanced NSCLC. more patients and longer follow up are mandatory. Kaywords: Phase III randomized thai. locally-advanced non-smail cell lung cancer, induction chemotherapy, concurrent chemoracictheraby Actmowledgement: This work was supported by 2003 Korean Nafional Cancer Center "Cancer ContToI Program"
[~3]
The efficacy and safety of padsxol (padltaxel) and clsplatln In advanced non-small cell lung Cancer
H. Kim ~, J. Kim 2, H. R y o J , D. Shin 4, C. Kim I , K. Park 2, S. Bae ~, B. Shim ~.
1St Vincent's Hospital, The Catholic University of Korea, Suwon, SouZh Korea, 2Korea Untversrty Medical Center, Seoul, South Korea: 3Daegu Catholic University Hospital, Daegu, SouZh Korea, 4Daegu Fatima Hospital, Daegu, SouZh Korea Background: Paclitaxel & cisplatin combinalJon chemotherapy is one of agents commonly used for non-small call lung cancer We conducted atnal to evaluate the efficacy & safety of Padexol (ne.~ genede of paditaxel produced by Shin Poong Pharm. Co.) in advanced non small call lung cancer. Methods: Pade~ol was given iv for 3 hrs with 175mg/m 2 which was followed by osplatin Iv with 75mg/m2/ Standard premodicat]on including steroid, ant]histamin & H2 blocker for Pad~ol. & hydration /antiomefica for clsplafin was gIven before chemotherapy.The inclusion criteria were pafionts w~h pathologically clagnosed inoperable or metastafic non small call lung cancer with measurable lesions, cherno nerve patients & pafients who fit other standard criteria The chemotherapy was repeated every 3 wks for a total of 6 cycles unless progressed The protocol was approved by IRB of each institutions and informed consent was signed by palJents Results: A total of 40 patients were enrolled from Jan to Nov 2064 The median age was 63years (range 47 74). & there were 32 male & 8. female The performance status was ECOG grade o in 10. 1 in 29 & 2 in 1 There were 20 squomous cell ca. 17 adenoca. & 3 others There palJents were not evaluablo for IT[ analysis (1 developed grade 3 dyspnea after 1st cydo. 1 clod suddenly after full-recovery from 2 na cycle. & 1 was late for 2 nd cycle) Nine patients were not evaiuablo for PP analysis(3 withdrew consent after 3rd cycle. 1 died of massive hemoptysis after 3 r~ cycle. 1 stopped after 3 r~ cycle for grade 3 neuropathy. & 1 developed pneumonia after 2 r~ cycle). A total of 169 cycles were given. Non~omatological grade 3/4 tc0ciclt]as developed in 22.5% of cyoles; nausea 3.6%. myalgia 3.0%. anorexia 2.4%. dyspnea 2.4%. general weakness 1 2%. hyponatremia 1 2%. mucositis 1 2%. nsuropathy 1 2%. & vom~ng 1 2% Hematological grade 3/4 to)dcifies developed in 1g 5% of cycles: nsutTopenia 11 2%. anemia 4 1%. febrile neutTopenia 1 2%. & leucocytobenia 1 2% There was no patient with chemotherapy related death There was no senous hypersensitivity reac~on There were 1 CR & 14 PR with overall response rate of 40 `5%(g`5%C1:24 5 56 6%) by ITI" analysis in 37 patients The overall resgese rate was 48 4%(g`5%CI 30,5 66 3%) by PP analysis in 31 patients. The response duration and survIval data will be presented. Conclusions: Padoxol (paclitaxel) & c~splafin combinafion chemotherapy was very active for advanced nor~smail cell lung cancer with lesser inc~donoe of severe myalgia or hypersensitIvity reaction. [ P ~ 4 ] Impact of thlrO-Ilne =t~emotherapy on long-term =Jrvlvom of advanced non-small ¢l~1 lung cancer (NSCLC) T Kim. S K i m . S P a r k . J Paek. I Choi. D Kim. T Kim. D Heo. YBang. N Kim Seou/National University Hos~tal, Seoul, Soulh Korea
Background: The aim of this study was to evaluate the role of third4ino chemotherapy for advanced non-small cell lung cancer patients who previously received paclitaxel- and gemcitabine~ased combinafion chemotherapy Methods: An analysis was performed on newly diagnosed patients with stage Ills or IV NSCLC who had received either paditaxel (P)- followed by gemcitabine (G)~)ased chemotherapy (P G: group A) or gemcitabinefollowed by paclitaxel~)ased chemotherapy (G P: group B) between January 2000 and October 2004. A total of 198 patients were evaluated. All pafients recaived combination chemotherapy wtth platinum compounds in first4ino Izeatmont. Among 198 patients, 133 patients received third line chemotherapy with gefit]nib monothorapy (38%) or other chemotherapy (62%).