bluuebunny/crossref_metadata_2025_split huggingface dataset:
Adjunctive local therapy in metastatic colorectal cancer in an unselected cohort: Improved patient-survival in comparison to systemic therapies.
Authors: Schroeder Jan , Tasci Evrim , Nolte-Ernsting Claus , Michels Peter , Wetzel Natalie , Scheiner-Sparna Renate , Stang Andreas 
Published: May 2020

4096 Background: Patients with distant metastases in colorectal cancer have a poor prognosis and a low overall survival (OS). In addition to systemic treatments and irradiation, the tumor burden can be reduced by loco-regional therapeutics, including microwave ablation (MWA), radiofrequency therapy (RFA) and trans-arterial chemoembolization (TACE) available. To evaluate the benefit of such local therapies, we compared OS of a single-centre study population to a reference population of patients who underwent no loco-regional treatment within the German Tumor Registry Colorectal Cancer (TKK). Methods: The study population consists of a cohort of 51 patients (n = 51) treated loco-regionally in addition to systemic therapy. The patients were recruited in a single cancer centre in Mülheim, Germany during the years 2006 to 2015. A reference population of 788 patients was chosen from a prospective, longitudinal registry of the TKK. Time to event data analysis included the estimation of Kaplan-Meier cumulative survival probabilities and hazard ratios (HR) with corresponding 95% confidence intervals (95% CI) from Cox proportional hazards regression. Results: The median OS was 31.3 months (95% CI 26.8 - 41.6) in the study population, as compared to the reference population, where it was 21.9 months (95% CI 20.1 – 24.6). Patients with liver and lung metastases in the study population had an OS of 41.6 months (95% CI 30.5 – 78.2), the corresponding patients from the reference population 21.7 months (95% CI 16.7 – 24.6). Furthermore, patients in the reference group had a 1.79-fold death-rate, as compared to patients treated with additional loco-regional therapy (HR = 2.02; 95% CI: 1.29-3.16). Conclusions: Additional treatment with loco-regional therapies of distant metastases in patients with metastatic colorectal cancer appears to be associated with improved OS by nearly 10 months compared to systemic treatments only. [Table: see text]
Immunoscore as a parameter predicting time to recurrence and disease-free survival in T4N0 stage II colon cancer patients.
Authors: Galon Jerome , Hermitte Fabienne , Mlecnik Bernhard , Lugli Alessandro , Bifulco Carlo Bruno , Nagtegaal Iris D. , Hartmann Arndt , Marliot Florence , Van Den Eynde Marc , Roehrl Michael H. A. , Ohashi Pamela S , Zavadova Eva , Torigoe Toshihiko , Patel Prabhudas S. , Wang Yili , Kawakami Yutaka , Marincola Francesco , Ascierto Paolo Antonio , Fox Bernard A. , Pages Franck 
Published: May 2020

4105 Background: Risk assessment is particularly important to decide when to propose an adjuvant treatment for Stage II Colon Cancer (CC) patients. However, the current tumor risk features are imperfect and additional risk factors are needed to guide treatment decisions. The consensus Immunoscore is an alternative and powerful approach that could be used in the T4N0 Stage II colon cancer population. Immunoscore is an in vitro diagnostic test that predicts the risk of relapse in patients with CC by measuring the host immune response at the tumor site. Methods: From the international Immunoscore consortium study (n = 2681) (Pagès et al. The Lancet 2018), a subgroup analysis was performed on T4N0 Stage II colon cancer patients (n = 208). Results: In stage II T4N0, Int+Hi Immunoscore represented 65.4% of the population and low-Immunoscore only 34.6%. T4N0 patients with Int+Hi Immunoscore presented a significantly prolonged survival for TTR compared to low Immunoscore patients (5 years recurrence rate Int+Hi: 84.6% (78.3-91.5), Lo: 46.3% (35.1-61); unadjusted HR [Int+Hi vs Lo] = 0.21; (95% CI 0.11-0.4); P< 0.0001), representing a restricted mean survival time (RMST) difference of 80.9 months (95% CI 51.1-110.6) ( P< 0.0001). The DFS was significantly different between Int+Hi and Low Immunoscore (5 years recurrence rate Int+Hi: 70.5% (95% CI 62.7-79.1), Lo: 38.5% (95% CI 28.2-52.5); unadjusted HR [Int+Hi vs Lo] = 0.31; (95% CI 0.19-0.49); P< 0.0001). Using restricted mean survival time (RMST) a significant ( P< 0.0001) difference of 60.4 months (95% CI 32.6-88.1) was observed between the 2 groups Importantly, Cox multivariate analysis in Stage II T4N0 colon cancer patients, revealed that Immunoscore was the only remaining significant parameter (HR [Int+Hi vs Lo] = 0.15; (95% CI 0.05-0.46); P= 0.0009). In contrast, all other parameters, gender, sidedness, mucinous, grade, T-stage, VELIPI, MSI were not significant in multivariate analysis. Finally, Immunoscore showed the highest relative contribution to predict relapse (76.2% chi2 relative contribution), stronger than all the other parameters, MSI (16.1%), Grade (5%), sidedness (2%), gender (2%), VELIPI (1%). Conclusions: Immunoscore is the most powerful parameter to predict the risk in T4N0 population, and could be a good tool for adjuvant treatment decision in Stage II patients.
Intrathoracic versus cervical anastomosis after minimally invasive esophagectomy for esophageal cancer: A randomized controlled trial.
Authors: Verstegen Moniek , van Workum Frans , Klarenbeek Bastiaan , Gisbertz Suzanne , Hannink Gerjon , Haveman Jan Willem , Heisterkamp Joos , Kouwenhoven Ewout , Van Lanschot Jan , Nieuwenhuijzen Grard , Van der Peet Donald , Polat Fatih , Rovers Maroeska , Rosman Camiel ,   ICAN Trial Study Group
Published: May 2020

4509 Background: Robust evidence is lacking whether Ivor Lewis minimally invasive esophagectomy (MIE) or McKeown MIE should be preferred for patients with mid to distal esophageal or gastro-esophageal junction Siewert I-II (GEJ) cancer. Methods: In this multicenter randomized controlled trial, patients with esophageal (below the level of the carina) or GEJ cancer planned for curative resection were recruited. Eligible patients were randomly assigned (1:1) to either Ivor Lewis MIE or McKeown MIE. The primary endpoint was anastomotic leakage (AL) requiring endoscopic, radiologic or surgical intervention. Secondary outcome parameters were overall AL rate, postoperative complications, length of stay and mortality. Results: A total of 262 patients were randomly assigned to Ivor Lewis MIE (n = 130) or McKeown MIE (n = 132). Seventeen patients were excluded from the trial due to not meeting inclusion criteria (n = 2), physical unfitness for surgery (n = 3), patients’ choice (n = 3), interval metastases (n = 5) or peroperative metastases (n = 4). AL necessitating reintervention occurred in 15 (12.3%) of 122 patients after Ivor Lewis MIE and in 39 (31.7%) of 123 patients after McKeown MIE (relative risk 0.39, 95% CI 0.22-0.65; risk difference 19.4%, 95% CI 7.9%-31.8%). Overall AL rate was 12.3% after Ivor Lewis MIE and 34.1% after McKeown MIE. Severe complications (Clavien-Dindo ≥ 3b) were observed in 10.7% after Ivor Lewis MIE and in 22.0% after McKeown MIE. Pleural effusion requiring drainage occurred in 9.8% of patients after Ivor Lewis MIE and 21.1% of patients after McKeown MIE. RLN palsy rate was 0% after Ivor Lewis MIE and 7.3% after McKeown MIE. Median length of hospital stay was 10 days (IQR 8 – 15 days) after Ivor Lewis MIE and 12 days (IQR 9 – 18 days) after McKeown MIE. ICU length of stay and mortality rates were comparable between groups. Conclusions: These findings provide evidence for a lower rate of AL requiring reintervention after Ivor Lewis MIE compared to McKeown MIE for patients with mid to distal esophageal or GEJ cancer. Clinical trial information: NTR4333 .
Trastuzumab deruxtecan (T-DXd; DS-8201) in patients with HER2-positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma: A randomized, phase II, multicenter, open-label study (DESTINY-Gastric01).
Authors: Shitara Kohei , Bang Yung-Jue , Iwasa Satoru , Sugimoto Naotoshi , Ryu Min-hee , Sakai Daisuke , Chung Hyun Cheol , Kawakami Hisato , Yabusaki Hiroshi , Lee Jeeyun , Saito Kaku , Kawaguchi Yoshinori , Kamio Takahiro , Kojima Akihito , Sugihara Masahiro , Yamaguchi Kensei 
Published: May 2020

4513 Background: T-DXd is an antibody-drug conjugate composed of an anti-HER2 antibody, cleavable tetrapeptide-based linker, and topoisomerase I inhibitor. In a phase 1 trial of T-DXd (5.4 or 6.4 mg/kg), the objective response rate (ORR) was 43.2% (19/44) and median progression-free survival (mPFS) was 5.6 mo in patients with advanced HER2+ gastric cancer (GC). DESTINY-Gastric01 (DS8201-A-J202; NCT03329690) is an open-label, multicenter, randomized, phase 2 study of T-DXd in HER2-expressing advanced GC or GEJ adenocarcinoma; results are from the primary analyses for ORR and interim overall survival (OS) in HER2+ patients. Methods: Patients with centrally confirmed HER2+ (IHC 3+ or IHC 2+/ISH+ on archival tissue) GC that progressed on ≥ 2 prior lines were randomized 2:1 (T-DXd 6.4 mg/kg q3w or physician’s choice [PC] irinotecan or paclitaxel). All patients received prior HER2 therapy. Stratification factors were region, ECOG PS (0;1), and HER2 status. The primary endpoint was unconfirmed ORR by independent central review. Secondary endpoints were OS (alpha controlled), PFS, disease control rate (DCR), duration of response (DOR), and safety. Results: 187 patients received T-DXd (n = 125) or PC (n = 62 [55 irinotecan; 7 paclitaxel]); 79.7% Japan, 20.3% Korea. Patients had a median of 2 prior lines of therapy, and 44.4% had ≥ 3. At data cutoff (8 Nov 2019), 22.4% of T-DXd and 4.8% of PC patients remained on treatment. ORR was 51.3% (61/119; 11 CR and 50 PR) with T-DXd vs 14.3% (8/56; all PR) with PC ( P < .0001); confirmed ORR, 42.9% vs 12.5% ( P < .0001); DCR, 85.7% vs 62.5% ( P = .0005); mDOR, 11.3 vs 3.9 mo; mPFS, 5.6 vs 3.5 mo (HR, 0.47 [95% CI, 0.31-0.71]; P = .0003). OS was significantly prolonged with T-DXd (mOS, 12.5 vs 8.4 mo; HR, 0.59 [95% CI, 0.39-0.88]; P = .0097; prespecified O'Brien Fleming boundary, P = .0202); 12-month OS, 52.1% vs 28.9%. Grade ≥ 3 AEs occurred in 85.6% of patients with T-DXd vs 56.5% with PC; the most common were neutrophil count decreased (51.2%; 24.2%), anemia (37.6%; 22.6%), and white blood cell count decreased (20.8%; 11.3%). 12 patients (9.6%) had T-DXd–related interstitial lung disease (ILD; 2 grade 3, 1 grade 4, no grade 5) vs 0 with PC. 1 drug-related death (pneumonia [non-ILD] in the T-DXd arm) occurred. Conclusions: T-DXd demonstrated statistically significant and clinically meaningful improvements in ORR and OS compared with standard chemotherapy (paclitaxel or irinotecan) in patients with HER2+ advanced gastric or GEJ adenocarcinoma. Clinical trial information: NCT03329690 .
A phase II study of rh-endostatin combined with paclitaxel and nedaplatin in treating patients with recurrent or metastatic esophageal squamous cell carcinoma (ESCC).
Authors: Wang Zhiqiang , Li Yu-Hong , Wang De-Shen , Wang Fenghua , Ren Chao , Tan Qiong 
Published: May 2020

4522 Background: For patients (pts) with metastatic ESCC, the prognosis is poor. Rh-endostatin (endostar), a potent inhibitor of angiogenesis, has shown clinical activity when combined with chemoradiotherapy in treating locally advanced ESCC. This single-arm phase 2 study was designed to assess the efficacy and safety of endostar combined with paclitaxel and nedaplatin in treating pts with recurrent or metastatic ESCC. Methods: Eligible pts had recurrent or metastatic ESCC and Karnofsky score ≥70. Endostar (30 mg/day, continuous infusion, day 1-14) plus paclitaxel (150 mg/m2, day 4) and nedaplatin (80 mg/m2, day 4) were administered every 3 weeks for 6 cycles followed by maintenance therapy with endostar. Primary endpoint was progression-free survival (PFS). Secondary endpoints included objective response rate (ORR), disease control rate (DCR), overall survival (OS) and adverse events (AEs). Results: From January 2015 to August 2019, 53 pts were enrolled. 44 (83%) pts were male. The median age was 59 years. 43 (81%) pts had pathology of poor or moderate differentiated ESCC. The middle and lower thirds of the esophagus (81%) were the most common primary tumor sites. 11 (21%) patients had undergone esophagectomy. At the time of treatment, 49 (93%) pts were diagnosed with clinical stage IVB. The most common metastatic sites were lymph node (91%), lung (32%) and liver (26%). 50 pts were assessable for response. No complete response was observed. 21 pts achieved a best response of partial response and 14 pts had stable disease. ORR was 42% and DCR was 70%. The median PFS and OS was 5.1 months (95% CI 3.7-6.6 months) and 13.2 months (95% CI 8.0-18.4 months) respectively. The most common AEs observed during this study were anemia (49.1%), neutropenia (34%), fatigue (28.3%) and anorexia (26.4%). The most common Grade 3/4 AE observed was neutropenia (17%). Conclusions: The combination of endostar plus paclitaxel and nedaplatin is a well tolerated treatment modality with promising activity in previously untreated recurrent or metastatic ESCC. Its efficacy and safety could be further studied in randomized trials. Clinical trial information: NCT02350517 .
Tumor response and growth rate of nivolumab treatment in advanced gastric cancer: Real-world data from a large observational/translational study, JACCRO GC-08 (deliver trial).
Authors: Kawabata Ryohei , Sakamoto Yasuhiro , Inoue Eisuke , Ishiguro Atsushi , Akamaru Yusuke , Kito Yosuke , Takahashi Masazumi , Matsuyama Jin , Yabusaki Hiroshi , Makiyama Akitaka , Suzuki Takahisa , Tsuda Masahiro , Yasui Hisateru , Kawakami Hisato , Matoba Ryo , Muro Kei , Nakajima Takako Eguchi , Ichikawa Wataru , Fujii Masashi , Sunakawa Yu 
Published: May 2020

4527 Background: Nivolumab (Nivo) demonstrated survival benefit in previously treated gastric cancer (GC) patients (pts), with a response rate (RR) of 11% and a disease control rate (DCR) of 40% (Kang YK, et al. Lancet 2017). There are few real-world data of Nivo and its predictive markers are needed in GC. It has been demonstrated that some tumors grow rapidly after Nivo treatment, but the proportion is uncertain. Methods: DELIVER trial was a prospective, multicenter, observational/translational study which assessed pts with advanced GC treated with Nivo alone and ECOG Performance Status (PS) 0-2 (UMIN000030850). The aims were to evaluate the efficacy and safety of Nivo in real world, and to discover novel host-related immune-biomarkers (gut microbiome, genetic polymorphism, gene expression, and metabolome) using fecal and blood samples which were collected before and after Nivo treatment. The RR, DCR, progression-free survival, overall survival, and tumor growth rate (TGR) were estimated as the efficacy. The response was evaluated by first imaging based on RECIST version 1.1. The TGR was calculated as a percentage increase in tumor volume during 1 month (Champiat et al. Clin Cancer Res 2017). Results: A total of 501 pts was enrolled in this study from Mar 2018 to Aug 2019, and 487 pts were evaluable for analysis (median age 70-y, 71% male, ECOG PS0/1/2 42%/44%/14%, tub/por/sig 45%/41%/5%, 21% HER2-pos, 42% pts with ascites). The DCR was 39.2% (95%CI 34.9-43.7) in evaluable pts. In 282 pts with measurable lesions, the RR was 6.7% (95%CI 4.1-10.3) and DCR was 36.5%. Sub-analysis by patient background indicated that DCR was 41% for PS0, 42% for PS1, and 24% for PS2. In addition, the DCR was lower in pts with ascites compared to those without ascites (28.6% vs. 47.0%, p= 0.005). The TGR decreased after introduction of Nivo in 124 (56.6%) of 219 evaluable pts for TGR; however, 20.5% pts were identified as experiencing hyper-progressive disease (HPD) which was defined as a ≥2-fold increase of the TGR before and after Nivo. When defining HPD as a ≥2-fold increase of tumor growth kinetics ratio and 50% increase of tumor burden, 9.6% pts experienced it. Conclusions: The real-word data of the large observational trial showed a comparable DCR to that of clinical trial in advanced GC treated with Nivo. This trial revealed the tumor behavior and some pts who experienced rapid tumor growth after Nivo treatment in clinical practice; biomarkers for HPD and the definition should be established. Clinical trial information: UMIN000030850 .
Phase II study of intraperitoneal paclitaxel combined with S-1 plus cisplatin for gastric cancer with peritoneal metastasis: SP + IP PTX trial.
Authors: Kobayashi Daisuke , Fukushima Ryoji , Ota Mitsuhiko , Fushida Sachio , Yamashita Naoyuki , Yoshikawa Kozo , Ueda Shugo , Yabusaki Hiroshi , Kusumoto Tetsuya , Arigami Takaaki , Hidemura Akio , Omori Takeshi , Yamaguchi Hironori , Hirono Yasuo , Tsuji Yasushi , Kishi Kentaro , Tomita Toshihiko , Ishigami Hironori , Kitayama Joji , Kodera Yasuhiro ,   Japan Intraperitoneal Chemotherapy Study Group (JIPG)
Published: May 2020

4529 Background: Intraperitoneal (IP) chemotherapy is a promising treatment option for gastric cancer with peritoneal metastasis. Although a phase III study failed to show a statistically significant superiority of IP paclitaxel (PTX) combined with S-1 and intravenous PTX over S-1/cisplatin (SP), the standard of care as a first-line treatment in Japan, the sensitivity analysis suggested clinical efficacy of the IP PTX. Thus, attempts to combine IP PTX with other systemic therapies with higher efficacy have been warranted. After a dose-finding study, we sought to explore efficacy of a new regimen that combined IP PTX with SP. Methods: Gastric cancer patients with peritoneal metastasis confirmed by diagnostic imaging, laparoscopy or laparotomy were enrolled in the phase II multi-institutional prospective trial. In addition to the established SP regimen (S-1 administered orally at a dose of 80 mg/m2 bid for 21 days followed by a 14-day rest and cisplatin administered intravenously at a dose of 60 mg/m2 on day 8), IP PTX was administered on days 1, 8 and 22 at a dose of 20 mg/m2. The primary endpoint is overall survival (OS) rate at one year after treatment initiation. Secondary endpoints are progression free survival (PFS), response rate and toxicity. Results: Fifty-three patients were enrolled and fully evaluated for OS and toxicity. The median number of courses was 7 (range 1-20). The 1-year OS rate was 74% (95% CI, 60-83%). The median survival time was 19.4 months (95% CI, 16.7 months-). The 1-year PFS rate was 57% (95% CI, 42-69%). The overall response rate was 20% (95% CI, 1-72%) in 5 patients with target lesions. Cancer cells ceased to be detected by peritoneal cytology in 23 (64%) of 36 patients. Fourteen (26%) patients underwent gastrectomy after response to chemotherapy. The incidences of grade 3/4 hematological and non-hematological toxicities were 43% and 47%, respectively. The frequent grade 3/4 toxicities included neutropenia (23%), anemia (29%), diarrhea (13%) and anorexia (17%). Intraperitoneal catheter and implanted port-related complications were observed in 4 patients. There was 1 treatment-related death. Conclusions: IP PTX combined with SP is well tolerated and active in gastric cancer patients with peritoneal metastasis. Clinical trial information: UMIN000023000 .
Gastric inflammatory prognostic index (GIPI) to predict efficacy of PD-1/PD-L1 immune checkpoint inhibitors in metastatic gastroesophageal junction (GOJ)/gastric cancer (GC) patients.
Authors: Morelli Cristina , Formica Vincenzo , Patrikidou Anna , Murias Carmen , Butt Sabeeh-Ur-Rehman , Nardecchia Antonella , Lucchetti Jessica , Renzi Nicola , Shiu Kai-Keen , Roselli Mario , Arkenau Tobias 
Published: May 2020

4530 Background: ICIs demonstrated improved overall survival (OS) in heavily pre-treated mGOJ/GC pts. Pts selection exclusively based on PD-L1 tissue expression appears to be suboptimal, despite data from subgroup analyses of KEYNOTE trials. Strong rationale suggests a potential predictive role of inflammatory biomarkers in ICIs treated mGOJ/GC pts. Methods: Ten systemic inflammatory markers [platelets, monocytes, neutrophil/lymphocyte ratio (NLR), platelets-lymphocyte ratio, lymphocytes, sum of mononuclear cells, albumin, lactate dehydrogenase, c-reactive protein (CRP) and serum globulin] were retrospectively analyzed at baseline in 57 mGOJ/GC pts with unknown PD-L1 status treated in second-line with ICIs, and correlated with OS. Least Absolute Shrinkage and Selection Operator (LASSO) method was used to select variables (preliminarily subject to optimal coding using HR smoothed curves for OS) with the highest prognostic value. Selected variables were then analyzed in a multivariate Cox Regression Model and used to build a GIPI nomogram. Results: NLR and CRP taken as continuous variables and albumin categorized as < vs > 30 g/dL were found as the most meaningful independent predictors of OS and used to build the GIPI nomogram. Nomogram-based lowest (l), mid-low, mid-high and highest (h) risk quartiles were associated with median(m)OS of 14.9, 7.1, 5.6 and 2.1 months (mos), respectively [HR of l vs h 4.94, p 0.0002]. By optimally dichotomizing CRP and NLR, pts with one or more of the following risk factors: NLR >6, CRP >15 mg/L, albumin <30 g/dL (n: 29) had a mOS of 3.9 mos vs 14.2 mos of pts with no risk factor (n: 28) (HR 2.48, p 0.001). Conclusions: GIPI, combining NLR, CRP and Albumin, is the first inflammatory index with a significant prognostic value in mOGJ/GC pts receiving second-line ICIs. Its implementation in correlation with PD-L1 expression in the present cohort is ongoing. GIPI merits validation in independent cohorts and prospective clinical trials.
Impact of frontline doublet versus triplet therapy on clinical outcomes: Exploratory analysis from the RAINBOW study.
Authors: Klempner Samuel J , Wainberg Zev A. , Muro Kei , Chao Joseph , Catenacci Daniel V.T. , Ajani Jaffer A. , Al-Batran Salah-Eddin , Toms Nikki , Knoderer Holly , Wei Ran , Liepa Astra M. , Chatterjee Anindya , Ohtsu Atsushi 
Published: May 2020

4543 Background: Treatment (tx) of advanced gastric cancer (GC/GEJ) is highly heterogeneous, with substantial variability in tx patterns. Frontline tx choice may affect outcomes of subsequent tx, thereby influencing choice/efficacy of second-line (2L) tx. In RAINBOW, 2L ramucirumab(R) plus paclitaxel(P) significantly improved overall survival (OS) of patients (pts) with GC/GEJ. Here we explore efficacy, safety and quality of life (QoL) based on prior tx. Methods: Pts were grouped into doublet (DB) or triplet (TP) regimens based on prior cytotoxic tx received. OS and PFS were estimated using Kaplan-Meier method and tx effects on OS and PFS were evaluated by Cox PH model; safety and QoL were assessed descriptively for DB vs TP. Results: Use of DB and TP was similar between arms, with 23% in R+P and 26% in placebo (PB)+P arm receiving TP. Baseline characteristics were generally balanced between tx arms within DB and TP subgroups, with majority of TP administered in western regions (91%). Pts ≥65 years of age was 40% for DB and 28% for TP. DB pts (n = 498; 75%) received S1+cis (n = 97, 15%) and cape+ox (n = 71; 11%) as most common prior tx, while TP pts (n = 163; 25%) received epi+cape+ox (n = 74, 11%) and epi+cis+5FU (n = 53, 8%). Similar to ITT population, R+P improved OS and PFS in both DB and TP subgroups (Table). Patterns of overall and Grade ≥3 TEAEs between arms were similar regardless of prior tx. Higher rates of serious TEAEs were reported in TP pts (57%, 49%) than DB pts (44%, 40%) in R+P and PBO+P arms, respectively. Similar trend was observed for TEAEs leading to discontinuation for TP (40%, 30%) vs DB (29%, 22%) in respective tx arms. Baseline QoL scores were similar between tx arms within subgroups, but mean scores were > 5 points worse (range 0-100) for prior TP for role functioning, fatigue, pain, and appetite loss. Changes in mean scores were generally similar between arms and within subgroups. Conclusions: This exploratory analysis of RAINBOW suggests that although safety-related outcomes were less favorable in pts with prior TP, regardless of tx arm, similar improvements in efficacy were noted for R+P irrespective of prior DB or TP. Clinical trial information: NCT01170663 . [Table: see text]