Racial disparities in lung cancer incidence and mortality over the last two decades; a Population-Based Study

Racial disparities in lung cancer incidence and mortality over the last two decades; a Population-Based Study

abstracts Annals of Oncology MO2  12  4 Preliminary Phase 1 Results of the PD-1 Inhibitor ABBV-181 in Japanese vs Western Patients With Advanced S...

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Annals of Oncology MO2  12  4

Preliminary Phase 1 Results of the PD-1 Inhibitor ABBV-181 in Japanese vs Western Patients With Advanced Solid Tumors

Background: ABBV-181 is a monoclonal antibody that binds to cell surface programmed cell death 1 (PD-1). Dose-finding data have been previously reported (Powderly et al, Ann Oncol 2018). This report summarizes ABBV-181 monotherapy data from Japanese (JPN) and cohort-matched Western (WST) patients (pts) enrolled in the first-in-human study evaluating ABBV-181 in pts with previously treated advanced solid tumors (NCT03000257). Methods: Pts received ABBV-181 in a 3 þ 3 dose-escalation design at 1, 3, and 10 mg/ kg IV every 2 weeks (Q2W) until progression (JPN pts: 3 and 10 mg/kg only) and a basket expansion cohort at a recommended phase 2 dose (RP2D). Response was assessed Q8W per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 and immune RECIST. Serial pharmacokinetic (PK) and pharmacodynamic samples were collected. Results: As of Nov 2018, 56 pts (JPN: 11) were enrolled (total and JPN pts, median days on treatment [range], 1 mg/kg: 12, 120 [43-653]; 3 mg/kg: 10 and 4, 64 [1-134] and 29 [15-106]; 10 mg/kg: 11 and 4, 64 [1-225] and 29 [1-85]; basket: 23 and 3, 29 [1-353] and 15 [15-16]). Adverse events (AEs) were reported in (total, JPN pts): 10, 4 (3 mg/ kg); 10, 3 (10 mg/kg); and 22, 2 (basket), with 5, 1 (3 mg/kg); 4, 0 (10 mg/kg); and 15, 1 (basket) pts having Grade (G)3 AEs. No dose-limiting toxicities or drug-related G5 AEs were reported. The most common G  1 AEs in JPN pts were (%): pyrexia (36), anemia (27), constipation (18); G  3 AEs were: anemia, decreased appetite, progression (9% each, all unrelated to ABBV-181). One G5 AE of progression was reported. Seven of 11 JPN pts discontinued ABBV-181 (all for disease progression). ABBV181 PK appears dose-proportional and comparable in JPN and WST pts. ABBV-181 led to complete PD-1 receptor occupancy, similar kinetics of cytokine induction, and transient T-cell changes in JPN and WST pts. Conclusion: These results support a RP2D of 250 mg Q2W, 375 mg Q3W, or 500 mg Q4W in both JPN and WST pts.

MO2  13  1

MO2  13  5

Racial disparities in lung cancer incidence and mortality over the last two decades; a Population-Based Study

Mahmad wafa, Ahmad oussama Khoudeir1, Inas A. Ruhban2, Anas M. Saad1, Muneer J. Al-Husseini1, Mohamed M. Gad3,4 1 Faculty of Medicine, Ain Shams University, Cairo, Egypt, 2Pathology department, Faculty of Medicine, Damascus University, Damascus, Syria, 3Cleveland Clinic Foundation, Ohio, USA, 4Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina Background: Racial disparities in the incidence and survival of lung cancer patients have been thoroughly studied. However, large epidemiologic studies evaluating temporal trends based on race are not prevalent. In this study, we aim to evaluate trends of incidence and mortality of lung cancer patients with a focus on patients of Asian origins. Methods: We used SEER 18 database to study lung cancer cases in the US during 20002015. Incidence and mortality rates of lung cancer were calculated by race and were expressed by 100,000 person-years. Annual percent change (APC) was calculated using joinpoint regression software. All statistical tests were two-sided. Results: 794,319 patients with lung cancer were identified. Most patients were whites (83.32%), followed by blacks (10.85%), Asians (5.37%), and American Indians (4.68%), with incidence rates of 60.86, 67.538, 37.325, and 32.195 per 100,000 personyears, respectively. Incidence rates of lung cancer decreased significantly among Asians during the study period, with this decrease being more prominent since 2012 (APC¼3.148%, p-value¼ 0.018). Similar trends were observed in other races. Mortality due to lung cancer was 49.001, 56.245, 28.916, and 27.980 per 100,000 person-years in whites, blacks, Asians, and American Indians, respectively. Mortality rates of both Asians increased significantly from 2000-2009 (APC¼2.429%, P<.001) until it stabilized in 2009 and started to decrease since 2013 (APC¼-30.14%, p-value < 0.001). Conclusion: Patients of Asian origins have shown lower incidence and mortality rates of lung cancer when compared to whites or blacks. Despite the declining incidence of lung cancer in Asians, mortality was inclining early 2000s yet started to decline since 2013. Understanding the root causes of the earlier incline and later decline can help improve survival in Asian lung cancer patients and lead to a further decline in mortality rates in the near future.

Randomized phase II trial of CBDCA1nab-PTX vs CDDP1GEM in patients with chemo-naı¨ve squamous cell lung cancer: NJLCG1302

Yuka Fujita1, Yosuke Kawashima2, Toshiyuki Harada3, Taku Nakagawa4, Kana Watanabe5, Naoto Morikawa6, Kei Takamura7, Kenya Kanazawa8, Tomoya Kuda9, Kazuhiro Usui10, Akimasa Sekine11, Akira Inoue12, Shunichi Sugawara2 1 Department of Respiratory Medicine, National Hospital Organization Asahikawa Medical Center, 2Department of Pulmonary Medicine, Sendai Kousei Hospital, 3 Department of Respiratory Medicine, JCHO Hokkaido Hospital, 4Department of Thoracic Surgery, Omagari Kosei Medical Center, 5Department of Respiratory Medicine, Miyagi Cancer Center, 6Division of Pulmonary Medicine, Allergy, and Rheumatology, Iwate Medical University School of Medicine, 7Department of Pulmonary Medicine, Obihiro Kosei Hospital, 8Department of Pulmonary Medicine, Fukushima Medical University School of Medicine, 9Department of Respiratory Medicine, Naha City Hospital, 10Division of Respirology, NTT Medical Center Tokyo, 11Department of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, 12Department of Palliative Medicine, Tohoku University School of Medicine Background: The subset analysis of CA031 trial showed a significant improvement of overall response rate (ORR) for carboplatin (CBDCA) plus weekly nab-paclitaxel (CnP) versus CBDCA plus paclitaxel in patients (pts) with squamous cell histology (41% vs 24%). We conducted a phase II study comparing CnP to cisplatin plus gemcitabine (CG), one of the standard regimens in pts with squamous cell lung cancer (SCC). Methods: Chemo-naı¨ve stage IIIB/IV or postoperative recurrent SCC pts were randomly assigned to receive either cisplatin (80 mg/m2) on day 1 plus gemcitabine (1000 mg/m2) on days 1, 8 every 3 weeks or CBDCA (AUC 6 mg/ml/min) on day 1 plus nab-PTX (75 mg/m2) on days 1, 8, 15 every 3 weeks. The primary endpoint was ORR. Secondary endpoints were progression-free survival (PFS), overall survival (OS), disease control rate (DCR) and toxicity. Assuming that an ORR of 40% in eligible pts indicates potential usefulness and ORR of 20% is the lower limit of interest, the estimated accrual was 32 pts in each arm. Allowing for dropouts, the accrual goal was determined to be 35 pts in each arm (alpha, 0.05; beta, 0.20). Results: Between June 2013 and October 2018, 71 pts were enrolled and assigned to CG arm (n ¼ 35) and CnP arm (n ¼ 36). The median follow-up time was 10.2 months. At data cutoff, ORR was 40% (95% confidence interval [CI]: 24.5-55.5) in CG arm and 47% (95%CI: 31.7-62.7) in CnP arm. DCR was 74% in CG arm and 80% in CnP arm. Median PFS was 4.6 months in CG arm and 4.3 months in CnP arm. Median OS was

Volume 30 | Supplement 6 | October 2019

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Randomized phase II study of CDDP1S-1 vs CDDP1PEM combined with thoracic RT for locally advanced nonsquamous NSCLC

Atsushi Horiike1, Makoto Nishio1, Seiji Niho2, Tatsuya Yoshida3, Tetsuo Akimoto4, Kentaro Sakamaki5,6, Toshiaki Takahashi7, Takashi Seto8, Noboru Yamamoto3, Toyoaki Hida9, Hiroaki Okamoto10, Takayasu Kurata11, Miyako Satouchi12, Koichi Goto2, Takeharu Yamanaka6, Yuichiro Ohe3 1 Department of Thoracic Medical Oncology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, 2Department of Thoracic Oncology, National Cancer Center Hospital East, 3Department of Thoracic Oncology, National Cancer Center Hospital, 4Division of Radiation Oncology and Particle Therapy, National Cancer Center Hospital East, 5Department of Biostatistics and Bioinformatics, Graduate School of Medicine, The University of Tokyo, 6Department of Biostatistics, Yokohama City University School of Medicine, 7Division of Thoracic Oncology, Shizuoka Cancer Center, 8 Department of Thoracic Oncology, National Kyushu Cancer Center, 9Department of Thoracic Oncology, Aichi Cancer Center, 10Department of Respiratory Medicine, Yokohama Municipal Citizen’s Hospital, 11Department of Thoracic Oncology, Kansai Medical University Hospital, 12Department of Thoracic Oncology, Hyogo Cancer Center Background: We previously reported that toxicities were tolerable and manageable in both arms; however, febrile neutropenia was more frequently observed in the CDDPþS-1 arm. Response rate was 60%/64%. Here, we present primary analysis of 2year survival data. Methods: Patients were randomly assigned to receive CDDPþS-1 (CDDP 60mg/m2, d1, and S-1 80mg/m2, d1-14, q4w, up to 4 cycles) or CDDPþPEM (CDDP 75mg/m2, d1, and PEM 500mg/m2, d1, q3w, up to 4 cycles) combined with TRT 60Gy in 30 fractions. The primary endpoint was 2-year progression-free survival (PFS) rate. The sample size was set at 100 patients. Results: Between Jan 2013 and Oct 2016, 102 patients were enrolled in this study from 9 institutions in Japan. All 102 patients were eligible and assessable, of whom 52 were assigned to CDDPþS-1 and 50 to CDDPþPEM. Baseline characteristics were similar (CDDPþS-1/CDDPþPEM): median age (range) 64.5 (39-73)/63.5 (32-74) years; women, n ¼ 17 (33%)/n¼17 (34%); stage IIIB, n ¼ 21 (40%)/n¼20 (40%); ECOG PS of 1, n ¼ 14 (27%)/n¼14 (28%); never smoker, n ¼ 12 (23%)/n¼12 (24%); and adenocarcinoma, n ¼ 47(90%)/n¼45(90%); activating EGFR mutation, n ¼ 9 (17%)/n¼4

doi:10.1093/annonc/mdz338 | vi107

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Yasutoshi Kuboki1, Shunsuke Kondo2, Rasco Drew3, Powderly John4, Spira Alexander5, J. luke Jason6, Afar Daniel7, Englert Stefan8, Hideyuki Hashiba9, Lambert Stacie7, Parikh Apurvasena7, Eisuke Shimizu9, Vosganian Greg7, Toshihiko Doi1, Noboru Yamamoto2 1 Department of Experimental Therapeutics, National Cancer Center Hospital East, 2 National Cancer Center Hospital, Tokyo, 3Methodist Hospital, San Antonio, TX, USA, 4 Carolina BioOncology Institute, Huntersville, NC, USA, 5Virginia Cancer Specialists, Fairfax, VA, USA, 6The University of Chicago Medicine, Chicago, IL, USA, 7AbbVie Inc., Redwood City, CA, USA, 8AbbVie Inc., Ludwigshafen, Germany, 9Oncology TA, Clinical Development Solid Tumor, AbbVie GK, Tokyo, Japan

10.9 months in CG arm and 10.0 months in CnP arm. Of the grade 3 or higher adverse events, anemia was more common in CnP arm (CG, 17% and CnP, 53%). There was one treatment-related death in CG arm and no treatment-related death in CnP arm. Conclusions: In this study, both CnP and CG arms met the primary endpoint. Carboplatin-based CnP regimen was likely to be equivalent to CG for SCC.