bluuebunny/crossref_metadata_2025_split huggingface dataset:
Sequencing cell free DNA in patients receiving selective internal radiation therapy for colorectal liver metastases.
Authors: Winter Helen , Kaisaki P , Carter Rebecca , Cutts Anthony , Greenhalgh Tessa , Schuh Anna , Sharma Ricky A. , Taylor Jenny C 
Published: March 2017

646 Background: Tumour heterogeneity is a key determinants of cancer resistance. Serial sampling of cell free (cf)DNA may detect evolving somatic mutations. Monitoring cancers after therapies e.g. selective internal radiation therapy (SIRT) require new biomarkers as RECIST imaging was developed to assess response to chemotherapy and may not reflect tumour changes due to new therapeutic strategies. The utility of cfDNA to detect recurrence and predict response is emerging. The objective of this study was to sequence serial cfDNA samples from patients with liver predominant metastatic disease receiving SIRT, and explore the feasibility of using this method to detect evolution of somatic mutations after high dose radiation. Methods: A prospective imaging biomarker study was performed in patients with colorectal liver metastases (CRLM) receiving SIRT. Plasma was extracted and frozen within 4 hours at 3 time points: baseline, 4 and 10 weeks after SIRT. Ion Torrent Amplicon sequencing was performed using cancer hotspot panel v.2. Sequencing of primary tumours was obtained by pyrosequencing. Results: Twenty-four patients with CRLM were recruited from March – Dec 2015, and 18 had cfDNA extracted for sequencing at a minimum of two time points. Ion Torrent amplicon sequencing of baseline cfDNA showed high concordance with formalin-fixed paraffin-embedded (FFPE) tumour samples. Serial cfDNA sequencing in a patient with partial response by imaging, detected 22% KRAS G12C mutation at baseline, which decreased to 1.5% by 4 weeks, then was undetectable 10 weeks after SIRT. Sequencing of another patient’s cfDNA revealed persistence of KRAS G13D and a truncating APCmutation at both 4 and 10 weeks after SIRT, consistent with the patient’s progressive disease. Conclusions: Cell-free DNA is emerging as a biomarker in colorectal cancer. Our measurements of mutational status in baseline cfDNA and FFPE samples show high concordance. This study reports that serial cfDNA sequencing detects changes in mutational status and specific mutations following high dose radiation to the liver. This adds to the evidence of cfDNA as a tool to detect evolution of somatic mutations following therapy.
CEA response and depth of response (DpR) to predict clinical outcomes in patients (pts) with metastatic colorectal cancer (mCRC) treated with first-line cetuximab plus oxaliplatin-based chemotherapy: A sub-analysis of the JACCRO CC-05/06 trials.
Authors: Sunakawa Yu , Ichikawa Wataru , Tsuji Akihito , Denda Tadamichi , Segawa Yoshihiko , Negoro Yuji , Shimada Ken , Kochi Mitsugu , Nakamura Masato , Kotaka Masahito , Tanioka Hiroaki , Takagane Akinori , Tani Satoshi , Yamaguchi Tatsuro , Takeuchi Masahiro , Fujii Masashi , Nakajima Toshifusa 
Published: March 2017

648 Background: Carcinoembryonic antigen (CEA) decrease was faster and greater in cetuximab (cet) treatment than bevacizumab treatment and correlated with prolonged survival in mCRC pts receiving FOLFIRI plus cet (Michl M, et al. Ann Oncol 2016). We investigated if the CEA decrease is a surrogate for DpR reported to be associated with clinical outcomes. Methods: This study evaluated the association between the percentage of CEA decrease or DpR and clinical outcomes in pts with KRAS exon 2 wild-type from 2 phase II trials of 1st-line therapy; JACCRO CC-05 of cet plus FOLFOX ( n= 57, UMIN000004197) and CC-06 of cet plus SOX ( n= 61, UMIN000007022). The association was analyzed using Spearman’s rank correlation coefficient. The cut-off value of 75% CEA decrease was used for CEA response to discriminate CEA responders according to the previous report. The DpR was defined as the percentage of tumor shrinkage at the nadir as compared with the baseline values. Results: In total of 113 pts of the 2 trials in the full analysis set, 92 were eligible for analyses of both CEA and DpR. In the population consists of 92 evaluable pts, median progression-free survival (PFS) was 9.1 months, and median overall survival (OS) was 36.2 months. Median CEA decrease was 67.4% and median time to CEA nadir was 2.8 months similar to median time to DpR of 3.0 months. The DpR was associated with PFS and OS (rs= 0.56; P< 0.0001, rs= 0.39; P= 0.0090, respectively); moreover, CEA decrease correlated with PFS (rs= 0.56, P< 0.0001) as well as OS (rs= 0.35, P= 0.019). CEA responders showed significantly longer PFS [11.8 vs. 5.5 months; hazard ratio (HR) 0.46; 95% Cl, 0.28–0.73; P= 0.0009] and numerically longer OS (36.2 vs. 23.5 months; HR 0.57; 95% CI, 0.30-1.05; P= 0.072) than CEA non-responders. The CEA decrease was statistically significantly associated with DpR (rs= 0.44, P< 0.0001). Conclusions: Our study demonstrates that DpR and CEA response both correlated with clinical outcomes of 1st-line treatment with cet plus oxaliplatin-based chemotherapy. The CEA decrease may serve as a surrogate for DpR in 1st-line cet treatment.
Molecular profiling of adenocarcinoma of esophagogastric junction.
Authors: Suh Yun-Suhk , Na Deukchae , Kim Euihyun , Lee Ju-Seog , Chae Jeesoo , Min Jimin , Choi Boram , Kong Seong-Ho , Lee Hyuk-Joon , Kim Jong-Il , Lee Charles , Kim Woo Ho , Yang Han-Kwang 
Published: March 2017

65 Background: Biologic understanding of adenocarcinoma of esophagogastric junction (AEJ) and similarity to gastric or esophageal adenocarcinoma has been long standing controversial issue, especially according to Siewert classification. The purpose of our study is to evaluate molecular characteristics of AEJ compared to esophageal (EAC) or upper third gastric adenocarcinoma (UT) using next generation sequencing. Methods: We analyzed classifier genes between EAC and body/fundus gastric adenocarcinoma (GCBF) from The Cancer Genome Atlas (TCGA) cohort. Based on classifiers, class prediction model was developed with Bayesian compound covariate predictor (BCCP). According to Siewert classification, SNUH cohort is comprised of each 16 pairs of tumors and normal gastric mucosae of AEJII, III and UT groups for which whole exome and transcriptome sequencing was carried out. SNUH cohort (n = 48) and AEJ/cardia cancer of TCGA cohort (n = 48) were tested using class prediction model. Results: Between EAC (n = 78) and GCBF (n = 102) in TCGA cohort, we identified 5,520 differentially expressed genes ( P< 0.001), and chose each top and bottom 200 genes using fold-change rank as classifiers for prediction model. Cross validation for prediction model revealed 90.2% of sensitivity and 89.7% of specificity. AEJ/Cardia cancer in both cohorts showed spectrum transition of predictor gene expression, and 75% in TCGA cohort (AEJ/Cardia) and 81.2% in SNUH cohort (AEJ) is classified as GCBF type using cut-off as 0.5 of BCCP. In SNUH cohort, 68.8% of AEJII , 80.0% of AEJIII sparing gastroesophageal junction (GEJ) and all AEJIII involving GEJ was classified as GCBF type. GCBF type shows significantly higher proportion of undifferentiated and diffuse type than EAC. Conclusions: Molecular prediction using BCCP revealed spectrum transition of AEJ, and 75-81.2% of AEJ/cardia cancer was classified as GCBF. Especially, 68.8 of AEJII and more than 80.0% of AEJIII can be considered as GCBF irrespective of involvement of GEJ.
C-jun N-terminal kinase dependent autophagic cell death in cancer cells induced by Zanthoxylum fruit extract from Japanese pepper.
Authors: Kono Toru , Nozaki Reo , Bochimoto Hiroki , Watanabe Tsuyoshi , Oketani Kaori , Sakamaki Yuichi , Okubo Naoto , Nakagawa Koji , Takeda Hiroshi 
Published: March 2017

653 Background: Natural products constitute a promising resource for drug development including an anticancer drug. Zanthoxylum fruit, obtained from the Japanese pepper plant (Zanthoxylum piperitum De Candolle), and its extract (Zanthoxylum fruit extract, ZFE) is an important component of Daikenchuto, which is a form of Japanese traditional medicine. Recently, we have reported that Daikenchuto has an anticancer activity in vivo, however precise mechanism is still unclear. Therefore, we investigated the potential anticancer activity of ZFE as an inducer of autophagic cell death (ACD). Methods: ZFE powder was provided by Tsumura (Japan). We investigated the effect of ZFE on the morphology of six types of human cancer cells and normal cells by using phase contrast microscopy and electron microscopy. Knockdown of autophagy-related gene 5 (ATG5), which is an essential gene for autophagy, by transfecting small interfering RNA was performed and confirmed by quantitative RT-qPCR and Western blot analysis. Effect of bafilomycin A1 (Baf A1), an inhibitor of vacuolar type H+-ATPases, on the anticancer activity of ZFE was investigated. Western blot analysis revealed LC3-II levels, a marker of autophagy. Results: ZFE caused remarkable autophagy-like cytoplasmic vacuolization with the inhibition of cell proliferation and subsequent induction of cell death in human cancer cell lines, DLD-1, HepG2 and Caco-2 cells but not in A549, MCF-7 or WiDr cells. ZFE increased LC3-II protein levels. Suppression of an ATG5 using siRNA inhibited ZFE-induced cytoplasmic vacuolization and cell death. Moreover, ZFE increased the phosphorylation of c-jun N-terminal kinase (JNK) in cancer cells which can be induced cell death by ZFE and JNK inhibitor SP600125 attenuated both vacuolization and cell death induced by ZFE. Instead, ZFE-induced cell death was neither apoptosis nor necrosis according to the morphological perspective and the marker of apoptosis or necrosis. And normal intestinal cell was not affected by ZFE. Conclusions: ZFE induces JNK-dependent ACD, which appears to be the main mechanism underlying its anticancer activity, suggesting a promising starting point for anticancer drug development.
Updated efficacy, safety, and biomarker analyses of STEAM, a randomized, open-label, phase II trial of sequential (s) and concurrent (c) FOLFOXIRI-bevacizumab (BV) vs FOLFOX-BV for first-line (1L) treatment (tx) of patients with metastatic colorectal cancer (mCRC).
Authors: Hurwitz Herbert , Tan Benjamin R. , Reeves James Andrew , Xiong Henry Q. , Somer Bradley G. , Lenz Heinz-Josef , Hochster Howard S. , Scappaticci Frank , Palma John F. , Mancao Christoph , Lee John J. , Nicholas Alan , Sommer Nicolas , Bendell Johanna C. 
Published: March 2017

657 Background: STEAM (NCT01765582) assessed efficacy and safety of 1L cFOLFOXIRI-BV and sFOLFOXIRI-BV vs FOLFOX-BV. Updated efficacy, safety, and exploratory biomarker data are reported. Methods: 280 tx-naive pts with mCRC were randomized 1:1:1 to BV-containing (5 mg/kg q2w) arms (cFOLFOXIRI, sFOLFOXIRI [alternating FOLFOX and FOLFIRI every 4 weeks {q4w}], or FOLFOX) in a 4–6 month (mo) induction phase, followed by maintenance. Primary objectives include progression-free survival (PFS). Secondary objectives include overall survival (OS). Tumor-relevant biomarker evaluations were exploratory. Results: Median PFS significantly improved and median OS showed a positive trend with cFOLFOXIRI-BV vs FOLFOX-BV. PFS significantly improved with cFOLFOXFIRI-BV vs FOLFOX-BV in BRAF wild type (WT); there was a positive trend in RAS WT and mutant (MUT) pts; no tx difference observed in BRAF MUT pts. In the safety pop., (n = 271), 88% had Grade ≥ 3 tx emergent AEs: 91% cFOLFOXIRI-BV; 87% sFOLFOXIRI-BV; 86% FOLFOX-BV. Conclusions: Improved PFS and a positive trend in OS were observed for cFOLFOXIRI-BV vs FOLFOX-BV. A positive PFS trend was seen in RAS WT and MUT pts, with significantly improved PFS in BRAF WT. The small number of BRAF MUT pts precluded estimation of tx effects. AEs for all 3 txs were consistent with previous reports. Clinical trial information: NCT01765582. [Table: see text]
Unresectable colorectal cancer liver metastases treated with radioembolization: Updated survival analysis of the MORE study.
Authors: Kennedy Andrew S. , Cohn Michael , Coldwell Douglas M. , Drooz Alain , Ehrenwald Eduardo , Kaiser Adeel , Nutting Charles W. , Rose Steven C. , Wang Eric , Savin Michael 
Published: March 2017

666 Background: In December 2011, the Metastatic Colorectal Cancer Liver Metastases Outcomes after Radioembolization (MORE) study retrospectively analyzed 606 patients with unresectable colorectal liver metastases treated with radioembolization using Y-90 resin microspheres. At a median follow-up of 8.6 months, 503 of these patients had died. Here, we summarize survival outcomes from extended follow-up of the remaining patients through September 1, 2016. Methods: Extended survival surveillance was abstracted from patient charts and public records. Survival time was compared for prognostic variables using Kaplan-Meier estimates. Results: Survival data were analyzed for 574 of 606 patients with median follow-up of 9.5 months (IQR 12.9 months). Patients received a median (range) of 2 (0 to 6) lines of chemotherapy. Additional death dates were obtained on 71 patients, and median survival was 10.0 months (95% CI 9.2-11.8) -versus 9.6 (95% CI 9.0-11.1) months originally reported. Data confirm ECOG PS, disease stage, extent of liver involvement, liver function, metachronous metastasis, and prior chemotherapy as predictors of post-radioembolization survival. Conclusions: Long-term follow-up confirms the originally reported prognostic factors for survival and that radioembolization offers a favorable survival benefit for patients with unresectable colorectal cancer liver metastases, even among those who already received 3 or more lines of chemotherapy. [Table: see text]
Baseline creatinine clearance as an indicator of severe adverse events associated with oxaliplatin-based adjuvant chemotherapy in patients with stage III colon cancer: Safety analysis of the phase III Japanese ACHIEVE trial.
Authors: Nakamura Masato , Kotaka Masahito , Eto Tetsuya , Manaka Dai , Hasegawa Junichi , Takagane Akinori , Kato Takeshi , Munemoto Yoshinori , Nakamura Fumitaka , Bando Hiroyuki , Taniguchi Hiroki , Gamoh Makio , Shiozawa Manabu , Yamanaka Takeharu , Mizushima Tsunekazu , Sakamoto Junichi , Saji Shigetoyo , Ohtsu Atsushi , Mori Masaki , Yoshino Takayuki 
Published: March 2017

667 Background: The phase III ACHIEVE trial (JFMC47), a project of the International Duration Evaluation of Adjuvant Chemotherapy (IDEA), was established to prospectively analyze data from several randomized trials to test whether 3-month (arm 3) oxaliplatin-based adjuvant (FOLFOX4, mFOLFOX6, or XELOX) treatment is non-inferior to 6-month (arm 6) treatment in terms of disease-free survival in patients (pts) with stage III colon cancer. It aims to reveal the association between baseline characteristics and ≥ grade 3 adverse events (AEs) related to XELOX and mFOLFOX6, particularly focusing on the role of baseline creatinine clearance (CCr) on ≥ grade 3 AEs. Methods: This association was assessed using the Cox proportional hazards model. Results: During 2012–2014, 1,313 pts were randomized from 244 centers; 1,301 were included in the intention-to-treat population. Among the safety population (N = 1,277; 642, arm 3; 635, arm 6), the overall incidence of ≥ grade 3 AEs was 29% in arm 3 and 43% in arm 6 (p < 0.0001). Neuropathy of ≥ grade 2 was more frequent in arm 6 than in arm 3 (37% vs. 14%; p < 0.0001). Regarding the fluoropyrimidine backbone, grade 3–4 neutropenia was more with mFOLFOX6 than XELOX (30% vs. 12%), whereas grade 3–4 anorexia (2% vs. 5%) and grade 3–4 diarrhea (1% vs. 6%) were more with XELOX. Multivariate analysis, including treatment duration, regimen, CCr ( < 50 vs. > 50 mL/min), age, and sex, showed that CCr had a statistically significant impact on the occurrence of ≥ grade 3 AEs (hazard ratio = 0.44, p < 0.0001). Pts with CCr < 50 may have had more frequent ≥ grade 3 AEs independent of other factors, such as age. Conclusions: Grade 3 or higher AEs related to XELOX or mFOLFOX6 may be associated with the degree of CCr. Clinical trial information: UMIN 000008543.
Exploratory analysis of left- versus right-sided colorectal carcinoma in RAISE: A randomized, double-blind, phase 3 trial of ramucirumab (RAM) + FOLFIRI versus placebo (PBO) + FOLFIRI.
Authors: Portnoy David Craig , Obermannova Radka , Bodoky Gyorgy , Prausová Jana , Garcia-Carbonero Rocio , Ciuleanu Tudor-Eliade , Garcia Alfonso Pilar , Cohn Allen Lee , Van Cutsem Eric , Yamazaki Kentaro , Yoshino Takayuki , Lonardi Sara , Kim Tae Won , Yamaguchi Kensei , Grothey Axel , O Connor Juan Manuel , Hsu Yanzhi , Ferry David , Nasroulah Federico , Tabernero Josep 
Published: March 2017

668 Background: Ramucirumab is a human IgG1 monoclonal antibody antagonist of VEGFR-2. Overall survival (OS) and progression-free survival (PFS) in 2nd line FOLFIRI based treatment for metastatic colorectal cancer (mCRC) were improved with RAM therapy versus PBO in the RAISE trial. Recent work suggests mCRC primary tumor location is both prognostic and predictive; with improved OS and therapy-specific sensitivity observed in left (L)- vs right (R)-sided tumors. Given these findings, the RAISE trial data was subjected to post-hoc analysis to determine if sidedness influenced RAM efficacy. Methods: Primary tumor site was obtained. L-CRC was defined as the splenic flexure, descending and sigmoid colon, and rectum, while R-CRC included transverse, ascending colon and cecum. OS/PFS in L and R subgroups were analyzed via Kaplan-Meier method and unstratified log-rank test (treatments within subgroup), unstratified Cox proportional hazards model (estimate hazard ratio [HR] and 95% CI), and Wald test (treatment-by-subgroup interaction). Results: Tumor location was available for 1012/1072 (94%) patients, 699 L- and 313 R-CRC. Baseline characteristics were balanced between arms. RAM treatment enhanced L-CRC median OS by 2.5 mo (median 14.5 vs 12.0 mo) with a HR (95% CI) = 0.807 (0.675, 0.965), P = 0.019; compared to a 1.1 mo increase in median OS in R-CRC vs PBO (12.7 vs 11.6) with a HR (95% CI) = 0.971 (0.750, 1.258), P = 0.823; and, RAM enhanced L-CRC median PFS by 1.6 mo (6.0 vs 4.4 mo) and HR (95% CI) = 0.776 (0.664, 0.906), P = 0.001 compared to a 1.1 mo increase in median PFS R-CRC vs PBO (5.6 vs 4.5) with a HR (95% CI) = 0.855 (0.674, 1.084), P = 0.197. The treatment-by-subgroup interaction for both OS and PFS was not significant ( P = 0.276, 0.578, respectively). Conclusions: Despite L-CRC patients having longer OS/PFS and a seemingly stronger RAM treatment effect than R-CRC, the non-significant interaction test cannot verify sidedness as being predictive of RAM efficacy. The current study confirms ramucirumab benefits mCRC patients regardless primary tumor location. Clinical trial information: NCT01183780.
Association of delayed commencement of adjuvant chemotherapy (AC) with inferior survival in colon cancer patients with stage II and III diseases: A national population-based cohort study.
Authors: Kim Ik Yong , Kim Young Wan 
Published: March 2017

669 Background: To evaluate factors affecting the delay ( ≥ 8 weeks) of AC and the impact of chemotherapy delay on survival in patients with colon cancer(CC). Methods: The study cohort consisted of patients with stage II and III colon cancer, diagnosed between January 1, 2011 and December 31, 2012, who underwent curative resection and AC at all hospitals registered in the Korean Health Insurance Review and Assessment Service (HIRA). Detailed clinical data are from monitoring and evaluation of quality of colon cancer care. Results: Among 5355 patients, 154 (2.9%) received AC more than 8 weeks after surgery. Based on multivariate analysis, risk factors associated with AC delay ≥ 8 weeks were: older age [65 to 74 years (hazard ratio, HR = 1.48) and 75 years (HR = 1.69), p = 0.0354], medical aid status in health security system (HR = 1.76, p = 0.0345), emergency surgery (HR = 2.43, p = 0.0002), and chemotherapy with fluoropyrimidine (HR = 1.49, p = 0.0373). Independent prognostic factors for inferior OS included AC delay ≥ 8 weeks (HR = 1.49, p = 0.0365), older age [65 to 74 years (HR = 1.94) and 75 years (HR = 3.41), p < 0.0001], TNM III stage (HR = 2.46, p < 0.0001), emergency surgery (HR = 1.89, p < 0.0001), ASA score with 3 or higher (HR = 1.50, p < 0.0001), and higher transfusion amount (HR = 1.09, p = 0.0392). OS rates in patients with stage II / III CCs according to delay of AC using 8 weeks cutoff showed inferior OS in the delayed chemotherapy group (p = 0.008).Detailed OS rates were 97.81% at 1 year, 93.77% at 2 year, 89.62% at 3 year, and 85.79% at 4 year in the chemotherapy group within 8weeks. In the delayed chemotherapy group ≥ 8 weeks, OS rates were 96.1% at 1 year, 87.66% at 2 year, 80.98% at 3 year, and 80.2% at 4 year. Conclusions: This national population-based cohort study shows that delayed commencement of AC, defined as ≥ 8 weeks, is associated with inferior OS in CC patients with stage II / III. To reduce the proportion of patients receiving delayed AC, multidimensional aspects such as health insurance status or age should be considered. Based on our results, the time of commencement of chemotherapy can be incorporated as another quality indicator for colon cancer care.
Nintedanib (N) plus best supportive care (BSC) versus placebo plus BSC for the treatment of patients (pts) with metastatic colorectal cancer (mCRC) refractory to standard therapies: Health-related quality of life (HRQoL) results of the Phase III LUME-Colon 1 study.
Authors: Lenz Heinz-Josef , Tabernero Josep , Yoshino Takayuki , Lonardi Sara , Falcone Alfredo , Limón Mirón María Luisa , Saunders Mark P. , Sobrero Alberto F. , Park Young Suk , Ferreiro Monteagudo Reyes , Hong Yong Sang , Tomasek Jiri , Taniguchi Hiroya , Ciardiello Fortunato , Sassi Mouna , Peil Barbara , Hastedt Claudia , Studeny Matus , Van Cutsem Eric 
Published: March 2017

671 Background: N is a multiple angiokinase inhibitor (including VEGFR, PDGFR and FGFR). A randomised Phase III study, LUME-Colon 1 (NCT02149108), evaluated the efficacy and safety of N in pts with refractory mCRC after failure of standard therapies. LUME-Colon 1 showed a statistically significant improvement in PFS (HR [95% CI] 0.58 [0.49–0.69]; p < 0.0001) but no difference in OS (HR [95% CI]: 1.01 [0.86–1.19]; p = 0.8659). Here, we report the HRQoL outcomes. Methods: 768 pts with mCRC adenocarcinoma refractory to standard chemotherapy were randomised 1:1 to receive either N (200 mg bid) + BSC or P (bid) + BSC in 21-day courses until disease progression or undue toxicity. HRQoL was assessed every 21 days using the EORTC QLQ-C30 instrument; the main endpoints of interest were the differences in mean scores up to median follow-up time (treatment difference, TD) for physical functioning (PF) and global health status/QoL (QL) scales using a longitudinal model, with 95% CIs and associated p-values adjusted for baseline stratification factors. Time to deterioration (TTD) of scores and status change ( ≥ 10 point change from baseline) were also assessed. Results: Compliance with questionnaire completion was high ( > 85% in first 12 cycles). Mean baseline (N vs P) PF (80 vs 80) and QL (65 vs 65) scale scores were balanced between treatment arms. The mean TD favoured N vs P for PF scale scores (TD 2.66 [95% CI: 0.97–4.34]; p = 0.0020) and QL scale scores (TD 1.61 [95% CI: −0.04–3.27]; p = 0.0555). TTD of PF (HR 0.84; 95% CI: 0.69–1.03; p = 0.0904) and QL (HR 0.90; 95% CI: 0.75–1.08; p = 0.2674) scores were not significantly different between treatment groups, although the percentage of patients with improved PF (17.2% vs 11.8%; p = 0.0462) and QL scores (30.3% vs 21.6%: p = 0.0102) were both significantly higher for N vs P. Conclusions: In LUME-Colon 1, patient reported outcomes confirmed that overall HRQoL was not impaired by treatment with N. There was evidence for improvement of PF and QL with N vs P, corresponding to the significant increase in PFS observed. Clinical trial information: NCT02149108.