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Does nutritional status affect treatment tolerability, response and survival in metastatic gastric cancer patients? Results of prospective multicenter study
abstracts
Annals of Oncology 792P
Does nutritional status affect treatment tolerability, response and survival in metastatic gastric cancer patients? Results of prospective multicenter study
gan1, N. Ak1, C. Usul Afsar2, M. Karabulut3, D. Tas¸tekin1 S. Karabulut1, I. Do 1 Medical Oncology Department, Istanbul University, Institute of Oncology, Istanbul, Turkey, 2Department of Internal Medicine and Medical Oncology, Acıbadem Bakırkoy Hospital, Faculty of Medicine, Istanbul, Turkey, 3Department of General Surgery, Health Sciences University, Bakırkoy Dr Sadi Konuk Education and Research Hospital, Istanbul, Turkey
793P
Ramucirumab use in patients with advanced gastric cancer (AGC) or gastro-oesophageal junction (GEJ) adenocarcinoma in Spain: RAMIS observational study
F. Longo Munoz1, M. Jorge Fernandez2, R. Yaya Tur3, S. Diaz4, M. Ortega4, T. Dilla4, A. Molero4, J.M. Cervera4 1 Medical Oncology, Hospital Universitario Ramon y Cajal, Madrid, Spain, 2Medical Oncology, Complejo Universitario Hospitalario De Vigo, Vigo, Pontevedra, Spain, 3 Medical Oncology, IVO - Fundacion Instituto Valenciano de Oncologia, Valencia, Spain, 4Medical Department, Eli Lilly Spain, Alcobendas, Spain Background: Ramucirumab (RAM), as a single agent, or combined with paclitaxel, is indicated for the treatment of patients with advanced gastric cancer (AGC) or gastroesophageal junction adenocarcinoma (GEJ) with disease progression on or after prior fluoropyrimidine- or/and platinum-containing chemotherapy. Until now, there are limited published data on the use of RAM in clinical practice. Methods: RAMIS was an observational, retrospective study carried out in 20 Spanish hospitals. Patients initiating RAM between Dec 2015 and Q4 2018 were eligible if aged 18 years, had AGC/GEJ and a complete medical record. Main objectives: patients characteristics, treatment patterns and effectiveness. Main analysis was descriptive; Kaplan-Meier method was used for time to event analysis. Exploratory analyses of predictors of effectiveness were performed. Results: 317 patients were included. Main characteristics at RAM initiation: 66.9% male, mean (SD) of 62.5 (11.3) years, 77.6% with AGC diagnosis, mean (SD) time since metastatic disease 1.0 (1.4) years. Patients had ECOG-0 (22.4%), 1 (63.1%) and 2 (10.4%), chronic comorbidities (62.5%), presented 1-2 metastatic sites (77.6%) and measurable disease (77.9%). Previous treatment was chemotherapy (97.2%). Most (93.7%) patients initiated RAM in combination with paclitaxel. Median time on treatment was 3.2 (2.8-3.4) months. Effectiveness results:
Volume 30 | Supplement 5 | October 2019
Progression Free Survival * Overall Survival (OS)*
Combination (N ¼ 297)
Monotherapy (N ¼ 20)
3.9 [3.4-4.3] 7.4 [6.4-8.9]
2.0 [1.1-2.8] 4.3 [1.9-7.3]
ies in real life conditions. Combination regimen, measurable disease, ECOG 0, and few metastatic sites were associated with better effectiveness outcomes. Editorial acknowledgement: IQVIA. Legal entity responsible for the study: Eli Lilly. Funding: Eli Lilly. Disclosure: F. Longo Munoz: Advisory / Consultancy, This study has been funded by Eli Lilly: Hospital Universitario Ram on y Cajal, Madrid, Spain. M. Jorge Fernandez: Advisory / Consultancy, This study has been funded by Eli Lilly: Hospital Alvaro Cunqueiro, Vigo (Pontevedra), Spain. R. Yaya Tur: Advisory / Consultancy, This study has been funded by Eli Lilly: IVO-Fundaci on Instituto Valenciano de Oncologia, Valencia, Spain. S. Diaz: Full / Part-time employment: Eli Lilly Spain. M. Ortega: Full / Part-time employment: Eli Lilly Spain. T. Dilla: Full / Part-time employment: Eli Lilly Spain. A. Molero: Full / Part-time employment: Eli Lilly Spain. J.M. Cervera: Full / Part-time employment: Eli Lilly Spain.
794P
Gastrectomy plus chemotherapy versus chemotherapy alone for advanced gastric cancer with a single non-curable factor: Exploratory analysis in the patients who were enrolled in JCOG0705/KGCA01 phase III trial (REGATTA) and could continue chemotherapy
T. Yoshikawa1, K. Fujitani2, H-K. Yang3, J. Mizusawa4, M. Terashima5, T. Tsujinaka6, K. Nakamura7, H. Katayama7, S-H. Jin8, S-H. Kong9, Y. Iwasaki10, H-H. Kim11, A. Takagane12, S-H. Lee13, J-M. Bae14, S.H. Noh15, M. Sasako16 1 Gastric Surgery, National Cancer Center Hospital, Tokyo, Japan, 2Gastrointestinal Surgery, Osaka General Medical Center, Osaka, Japan, 3Surgery & Cancer Research Institute, Seoul National University Hospital, Seoul, Republic of Korea, 4Japan Clinical Oncology Group Data Center, National Cancer Center Hospital, Tokyo, Japan, 5Division of Gastric Surgery, Shizuoka Cancer Center, Shizuoka, Japan, 6Surgery, Kaizuka City Hospital, Kaizuka, Japan, 7Japan Clinical Oncology Group Operations Office, National Cancer Center Hospital, Tokyo, Japan, 8Surgery, Korea Cancer Center Hospital, Seoul, Republic of Korea, 9Department of Surgery & Cancer Research Institute, Seoul National University Hospital, Seoul, Republic of Korea, 10Surgery, Komagome Tokyo Metropolitan Hospital, Tokyo, Japan, 11Surgery, Seoul National University Bundang Hospital, Seongnam, Republic of Korea, 12Surgery, Hakodate Goryokaku Hospital, Hakodate, Japan, 13Surgery, Kosin University Gospel Hospital, Pusan, Republic of Korea, 14Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea, 15Surgery, Gangnam Severance Hospital, Seoul, Republic of Korea, 16 Surgery, Yodogawa Christian Hospital, Osaka, Japan Background: REGATTA is a phase III trial to compare chemotherapy alone (arm A) and reduction surgery followed by chemotherapy (arm B) for advanced gastric cancer with a single non-curable factor. The trial failed to show superiority of reduction surgery, which could be partially explained by poor compliance of chemotherapy in arm B. This exploratory analysis aims to clarify whether upfront surgery has survival benefit in patients (pts) who could continue chemotherapy for some period, enrolled in REGATTA. Methods: In REGATTA, 175 pts were assigned to arm A (86 pts) and arm B (89 pts). S1 80 mg/m2 for 3 weeks and CDDP 60 mg/m2 on day 8 was repeated every 6 weeks. The pts were limited to those for whom chemotherapy was continued at 2, 4, or 6 months after randomization (cohort-2M, cohort-4M, or cohort-6M, respectively) and pts who underwent gastrectomy in arm A were excluded. The overall survival (OS) was defined as the duration from the date at 2, 4, or 6 months after randomization to the date of the death from any cause or to the last date of contact for a surviving pt. Results: Examined pts were 130 (59 in arm A and 71 in arm B) in cohort-2M, 111 (50 in arm A and 61 in arm B) in cohort-4M, and 90 (43 in arm A and 47 in arm B) in cohort-6M, respectively. In cohort-2M, the median survival time (MST) was 14.1 months (m) (95% CI, 11.7-16.6) in arm A and 12.6 m (9.9-15.9) in arm B with hazard ratio (HR) of 0.935 (0.641-1.635). The OS was 9.7% (3.2-20.5) in arm A and 17.9% (9.2-28.8) in arm B at 3-year. In cohort-4M, the MST was 13.1 m (10.3-18.8) in arm A
doi:10.1093/annonc/mdz247 | v305
Downloaded from https://academic.oup.com/annonc/article-abstract/30/Supplement_5/mdz247.118/5577282 by guest on 24 October 2019
Background: With this study, we aimed to present the impact of malnutrition on the tolerability and efficacy ofchemotheraphy, and overall survival on metastatic gastric cancer (mGC) patients. Methods: In this prospective multicenter study, we collected demographic, oncological and nutritional data for our mGC patients. Nutritional status was assessed with the Nutritional Risk Index (NRI), Body Mass Index (BMI) and clinical weight loss percentage with 21-day period during two chemotherapy cycles. NRI were calculated with formula as following; 1.519 x serum albumin level (g/L) þ 41.7 x current weight/basic weight. Patients were calssified as having ‘no’ (NRI >97.5), ‘moderate’ (97.5 NRI 83.5) or ‘severe’ (NRI <83.5) malnutrition. Drug-induced toxicities were evaluated using National Cancer Institute CTCAE version 4.0 and treatment responses were evaluated using RECIST Criteria 1.1. Results: 116 mGC patients enrolled. Median age was 60 years. Primary location of tumor was non-antrum/antrum with 60/40% and 24% of patients had experienced primary tumor resection. WHO performance status of patients was 0-1 for 98%. All treatments were first-line setting. 41% of patients dead of during follow up period (Median: 138 days, Range: 21-378). Malnurition diagnosed in 68 % of the patients and was severe in 32%. Moderate/severe malnutrution was associated with more treatment toxicity ( grade 2 cytopenia, nausea/vomiting, diarrhea, neuropathy; p < 0.05 for all parameters). Moderate/severe malnutrution was not associated with chemoteraphy responses (p ¼ 0.215). Malnutritional level was associated with significantly reduced overall survival (OS), none, moderately or severe malnourished groups, with 350 days (95% CI, 176.0 - 524.0), 210 (95 %CI, 166.3 - 253.7), 74 (95% CI, 20.7 - 111.0) respectively (p ¼ 0.025). Severe malnutition was associated with shorter OS (74 vs. 237 days in non/ moderatery, p ¼ 0.007). Conclusions: In mGC patients, moderate/severe malnutrition is associated with worse non-hematological chemotherapy toxicities. Malnutrition level and severe malnutrition is also associated reduced overall survival. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.
Table: 793P
Annals of Oncology 792P
Does nutritional status affect treatment tolerability, response and survival in metastatic gastric cancer patients? Results of prospective multicenter study
gan1, N. Ak1, C. Usul Afsar2, M. Karabulut3, D. Tas¸tekin1 S. Karabulut1, I. Do 1 Medical Oncology Department, Istanbul University, Institute of Oncology, Istanbul, Turkey, 2Department of Internal Medicine and Medical Oncology, Acıbadem Bakırkoy Hospital, Faculty of Medicine, Istanbul, Turkey, 3Department of General Surgery, Health Sciences University, Bakırkoy Dr Sadi Konuk Education and Research Hospital, Istanbul, Turkey
793P
Ramucirumab use in patients with advanced gastric cancer (AGC) or gastro-oesophageal junction (GEJ) adenocarcinoma in Spain: RAMIS observational study
F. Longo Munoz1, M. Jorge Fernandez2, R. Yaya Tur3, S. Diaz4, M. Ortega4, T. Dilla4, A. Molero4, J.M. Cervera4 1 Medical Oncology, Hospital Universitario Ramon y Cajal, Madrid, Spain, 2Medical Oncology, Complejo Universitario Hospitalario De Vigo, Vigo, Pontevedra, Spain, 3 Medical Oncology, IVO - Fundacion Instituto Valenciano de Oncologia, Valencia, Spain, 4Medical Department, Eli Lilly Spain, Alcobendas, Spain Background: Ramucirumab (RAM), as a single agent, or combined with paclitaxel, is indicated for the treatment of patients with advanced gastric cancer (AGC) or gastroesophageal junction adenocarcinoma (GEJ) with disease progression on or after prior fluoropyrimidine- or/and platinum-containing chemotherapy. Until now, there are limited published data on the use of RAM in clinical practice. Methods: RAMIS was an observational, retrospective study carried out in 20 Spanish hospitals. Patients initiating RAM between Dec 2015 and Q4 2018 were eligible if aged 18 years, had AGC/GEJ and a complete medical record. Main objectives: patients characteristics, treatment patterns and effectiveness. Main analysis was descriptive; Kaplan-Meier method was used for time to event analysis. Exploratory analyses of predictors of effectiveness were performed. Results: 317 patients were included. Main characteristics at RAM initiation: 66.9% male, mean (SD) of 62.5 (11.3) years, 77.6% with AGC diagnosis, mean (SD) time since metastatic disease 1.0 (1.4) years. Patients had ECOG-0 (22.4%), 1 (63.1%) and 2 (10.4%), chronic comorbidities (62.5%), presented 1-2 metastatic sites (77.6%) and measurable disease (77.9%). Previous treatment was chemotherapy (97.2%). Most (93.7%) patients initiated RAM in combination with paclitaxel. Median time on treatment was 3.2 (2.8-3.4) months. Effectiveness results:
Volume 30 | Supplement 5 | October 2019
Progression Free Survival * Overall Survival (OS)*
Combination (N ¼ 297)
Monotherapy (N ¼ 20)
3.9 [3.4-4.3] 7.4 [6.4-8.9]
2.0 [1.1-2.8] 4.3 [1.9-7.3]
ies in real life conditions. Combination regimen, measurable disease, ECOG 0, and few metastatic sites were associated with better effectiveness outcomes. Editorial acknowledgement: IQVIA. Legal entity responsible for the study: Eli Lilly. Funding: Eli Lilly. Disclosure: F. Longo Munoz: Advisory / Consultancy, This study has been funded by Eli Lilly: Hospital Universitario Ram on y Cajal, Madrid, Spain. M. Jorge Fernandez: Advisory / Consultancy, This study has been funded by Eli Lilly: Hospital Alvaro Cunqueiro, Vigo (Pontevedra), Spain. R. Yaya Tur: Advisory / Consultancy, This study has been funded by Eli Lilly: IVO-Fundaci on Instituto Valenciano de Oncologia, Valencia, Spain. S. Diaz: Full / Part-time employment: Eli Lilly Spain. M. Ortega: Full / Part-time employment: Eli Lilly Spain. T. Dilla: Full / Part-time employment: Eli Lilly Spain. A. Molero: Full / Part-time employment: Eli Lilly Spain. J.M. Cervera: Full / Part-time employment: Eli Lilly Spain.
794P
Gastrectomy plus chemotherapy versus chemotherapy alone for advanced gastric cancer with a single non-curable factor: Exploratory analysis in the patients who were enrolled in JCOG0705/KGCA01 phase III trial (REGATTA) and could continue chemotherapy
T. Yoshikawa1, K. Fujitani2, H-K. Yang3, J. Mizusawa4, M. Terashima5, T. Tsujinaka6, K. Nakamura7, H. Katayama7, S-H. Jin8, S-H. Kong9, Y. Iwasaki10, H-H. Kim11, A. Takagane12, S-H. Lee13, J-M. Bae14, S.H. Noh15, M. Sasako16 1 Gastric Surgery, National Cancer Center Hospital, Tokyo, Japan, 2Gastrointestinal Surgery, Osaka General Medical Center, Osaka, Japan, 3Surgery & Cancer Research Institute, Seoul National University Hospital, Seoul, Republic of Korea, 4Japan Clinical Oncology Group Data Center, National Cancer Center Hospital, Tokyo, Japan, 5Division of Gastric Surgery, Shizuoka Cancer Center, Shizuoka, Japan, 6Surgery, Kaizuka City Hospital, Kaizuka, Japan, 7Japan Clinical Oncology Group Operations Office, National Cancer Center Hospital, Tokyo, Japan, 8Surgery, Korea Cancer Center Hospital, Seoul, Republic of Korea, 9Department of Surgery & Cancer Research Institute, Seoul National University Hospital, Seoul, Republic of Korea, 10Surgery, Komagome Tokyo Metropolitan Hospital, Tokyo, Japan, 11Surgery, Seoul National University Bundang Hospital, Seongnam, Republic of Korea, 12Surgery, Hakodate Goryokaku Hospital, Hakodate, Japan, 13Surgery, Kosin University Gospel Hospital, Pusan, Republic of Korea, 14Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea, 15Surgery, Gangnam Severance Hospital, Seoul, Republic of Korea, 16 Surgery, Yodogawa Christian Hospital, Osaka, Japan Background: REGATTA is a phase III trial to compare chemotherapy alone (arm A) and reduction surgery followed by chemotherapy (arm B) for advanced gastric cancer with a single non-curable factor. The trial failed to show superiority of reduction surgery, which could be partially explained by poor compliance of chemotherapy in arm B. This exploratory analysis aims to clarify whether upfront surgery has survival benefit in patients (pts) who could continue chemotherapy for some period, enrolled in REGATTA. Methods: In REGATTA, 175 pts were assigned to arm A (86 pts) and arm B (89 pts). S1 80 mg/m2 for 3 weeks and CDDP 60 mg/m2 on day 8 was repeated every 6 weeks. The pts were limited to those for whom chemotherapy was continued at 2, 4, or 6 months after randomization (cohort-2M, cohort-4M, or cohort-6M, respectively) and pts who underwent gastrectomy in arm A were excluded. The overall survival (OS) was defined as the duration from the date at 2, 4, or 6 months after randomization to the date of the death from any cause or to the last date of contact for a surviving pt. Results: Examined pts were 130 (59 in arm A and 71 in arm B) in cohort-2M, 111 (50 in arm A and 61 in arm B) in cohort-4M, and 90 (43 in arm A and 47 in arm B) in cohort-6M, respectively. In cohort-2M, the median survival time (MST) was 14.1 months (m) (95% CI, 11.7-16.6) in arm A and 12.6 m (9.9-15.9) in arm B with hazard ratio (HR) of 0.935 (0.641-1.635). The OS was 9.7% (3.2-20.5) in arm A and 17.9% (9.2-28.8) in arm B at 3-year. In cohort-4M, the MST was 13.1 m (10.3-18.8) in arm A
doi:10.1093/annonc/mdz247 | v305
Downloaded from https://academic.oup.com/annonc/article-abstract/30/Supplement_5/mdz247.118/5577282 by guest on 24 October 2019
Background: With this study, we aimed to present the impact of malnutrition on the tolerability and efficacy ofchemotheraphy, and overall survival on metastatic gastric cancer (mGC) patients. Methods: In this prospective multicenter study, we collected demographic, oncological and nutritional data for our mGC patients. Nutritional status was assessed with the Nutritional Risk Index (NRI), Body Mass Index (BMI) and clinical weight loss percentage with 21-day period during two chemotherapy cycles. NRI were calculated with formula as following; 1.519 x serum albumin level (g/L) þ 41.7 x current weight/basic weight. Patients were calssified as having ‘no’ (NRI >97.5), ‘moderate’ (97.5 NRI 83.5) or ‘severe’ (NRI <83.5) malnutrition. Drug-induced toxicities were evaluated using National Cancer Institute CTCAE version 4.0 and treatment responses were evaluated using RECIST Criteria 1.1. Results: 116 mGC patients enrolled. Median age was 60 years. Primary location of tumor was non-antrum/antrum with 60/40% and 24% of patients had experienced primary tumor resection. WHO performance status of patients was 0-1 for 98%. All treatments were first-line setting. 41% of patients dead of during follow up period (Median: 138 days, Range: 21-378). Malnurition diagnosed in 68 % of the patients and was severe in 32%. Moderate/severe malnutrution was associated with more treatment toxicity ( grade 2 cytopenia, nausea/vomiting, diarrhea, neuropathy; p < 0.05 for all parameters). Moderate/severe malnutrution was not associated with chemoteraphy responses (p ¼ 0.215). Malnutritional level was associated with significantly reduced overall survival (OS), none, moderately or severe malnourished groups, with 350 days (95% CI, 176.0 - 524.0), 210 (95 %CI, 166.3 - 253.7), 74 (95% CI, 20.7 - 111.0) respectively (p ¼ 0.025). Severe malnutition was associated with shorter OS (74 vs. 237 days in non/ moderatery, p ¼ 0.007). Conclusions: In mGC patients, moderate/severe malnutrition is associated with worse non-hematological chemotherapy toxicities. Malnutrition level and severe malnutrition is also associated reduced overall survival. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.
Table: 793P