Subgroup analysis by baseline (BL) weight-associated parameters: A phase III study of liposomal irinotecan (nal-IRI)±5-fluorouracil/leucovorin (5-FU/LV) in patients (pts) with metastatic pancreatic ductal adenocarcinoma (mPDAC) previously treated with gemcitabine-based (gem) therapy.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 410-410
Author(s):  
Teresa Mercade Macarulla ◽  
Richard Hubner ◽  
Jean-Frédéric Blanc ◽  
Andrea Wang-Gillam ◽  
Chung-Pin Li ◽  
...  
Keyword(s):  
Subgroup Analysis ◽  
Analysis Data ◽  
Phase Iii ◽  
Ductal Adenocarcinoma ◽  
Independent Effect ◽  
P Value ◽  
Prognostic Impact ◽  
Value Range ◽  
Liposomal Irinotecan ◽  
Post Hoc

410 Background: We report prognostic evaluation of BL weight-associated parameters (body-mass index [BMI], body surface area [BSA] and weight) in pts with mPDAC after progression following gem-based therapy (NAPOLI-1 trial; NCT01494506). Pts received nal-IRI+5-FU/LV, nal-IRI monotherapy or 5-FU/LV in NAPOLI-1, an international, randomised, phase 3 trial; nal-IRI+5-FU/LV treatment resulted in a 45% increased median OS vs. 5-FU/LV (unstratified HR = 0.67; p = 0.012). Methods: This exploratory subgroup analysis compares outcomes by BL BMI, BSA and weight, using primary survival analysis data from the ITT population for all treatment arms combined (n = 417) and the nal-IRI+5-FU/LV arm on its own (n = 117). Results: OS and PFS were not significantly different between BL BMI, BSA and weight median subgroups in the entire NAPOLI-1 ITT population (HR range 1.06–1.15; log-rank p-value range 0.21–0.60; Table) and in the nal-IRI+5-FU/LV arm (HR range 0.94–1.19; log-rank p-value range 0.43–1.00). Conclusions: This post-hoc subgroup analysis did not detect any prognostic impact on treatment outcome by BL BMI, BSA and weight for mPDAC pts progressed following gem-based therapy. This observation rules out a treatment-independent effect. No evidence of a predictive effect on nal-IRI+5-FU/LV efficacy was found. Clinical trial information: NCT01494506. [Table: see text]

Subgroup analysis by prior lines of metastatic therapy (mtx) in NAPOLI-1: A global, randomized phase 3 study of liposomal irinotecan (nal-IRI) ± 5-fluorouracil and leucovorin (5-FU/LV), vs. 5-FU/LV in patients (pts) with metastatic pancreatic ductal adenocarcinoma (mPDAC) who have progressed following gemcitabine-based therapy.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 4127-4127
Author(s):  
Teresa Mercade Macarulla ◽  
Jens T. Siveke ◽  
Andrea Wang-Gillam ◽  
Chung-Pin Li ◽  
Gyorgy Bodoky ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Subgroup Analysis ◽  
Analysis Data ◽  
Ductal Adenocarcinoma ◽  
Phase 3 ◽  
Study Methodology ◽  
Liposomal Irinotecan ◽  
Grade 3 ◽  
Post Hoc ◽  
Clinical Trial Information

4127 Background: In the NAPOLI-1 study, nal-IRI+5-FU/LV significantly increased median OS vs. 5-FU/LV control (6.1 vs. 4.2 mo; unstratified HR = 0.67 [0.49–0.92]; p = .012). This is a subgroup analysis by prior lines of mtx. Methods: Study methodology has been published (Wang-Gillam; Lancet 2016). This exploratory subgroup analysis compares outcomes in pts with 0–1 vs. ≥2 prior mtx lines, based on primary survival analysis data (cut-off February 2014) of the ITT population. Results: OS, PFS and CA19-9 response rates in pts with 0–1 (65.8% of pts) or ≥2 (34.2%) prior mtx lines are shown (see Table). Median OS for nal-IRI+5-FU/LV improved vs. 5-FU/LV by 2.1 mo to 6.2 mo (HR = 0.66; p = .03) in pts with 0–1 prior mtx lines and by 1.1 mo to 5.4 mo (HR = 0.68; p = .18) in pts with ≥2 prior mtx lines. The safety profile was similar between subgroups with nal-IRI+5-FU/LV (≥grade 3 drug-related AEs: 43 [55%] with 0–1 and 20 [51%] with ≥2 prior mtx lines). Conclusions: This post-hoc subgroup analysis shows significant increases for nal-IRI+5-FU/LV over 5-FU/LV in OS, PFS and CA19-9 response in pts with 0–1 prior mtx lines. Median OS benefit was less prominent in later lines, but conclusions are restricted by limited pt numbers. Clinical trial information: NCT01494506. [Table: see text]

Subgroup analysis by baseline pain intensity (BPI) and analgesic use (BAU) in NAPOLI-1: A phase III study of liposomal irinotecan (nal IRI)±5-fluorouracil/ leucovorin (5-FU/LV) in patients (pts) with metastatic pancreatic ductal adenocarcinoma (mPDAC) previously treated with gemcitabine-based therapy.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 379-379
Author(s):  
Teresa Mercade Macarulla ◽  
Jens T. Siveke ◽  
Andrew Peter Dean ◽  
Richard Hubner ◽  
Jean-Frédéric Blanc ◽  
...  
Keyword(s):  
Subgroup Analysis ◽  
Phase Iii ◽  
Ductal Adenocarcinoma ◽  
Prognostic Effect ◽  
Baseline Pain Intensity ◽  
Phase Iii Study ◽  
Previously Treated ◽  
Recorded Data ◽  
Liposomal Irinotecan ◽  
Post Hoc

379 Background: We report an exploratory, post hoc subgroup analysis in pts with BPI and BAU data receiving nal-IRI+5-FU/LV, nal-IRI or 5-FU/LV in NAPOLI-1 (NCT01494506). In this pivotal trial, nal-IRI+5-FU/LV improved median OS (mOS) vs. 5-FU/LV (6.1 vs. 4.2 mo [HR=0.67; p=0.012]). Methods: BPI/BAU included an average of 3-7 days pt-recorded data before randomisation. Greater values indicated greater pain for BPI using a 100 mm visual analogue scale. BAU was converted to morphine equivalent mg/day. Results: Of 417 ITT pts, 295 had BPI and 299 had BAU data. Mean and median BPI were 28.6 and 25.0, respectively, and BAU were 33.3 and 8.1 mg/day, respectively. The percentage of pts with KPS ≥ 80 was higher in ≤ mean/≤ median (n=159/148) BPI groups vs. > mean/> median (n=136/147) BPI groups (96-97 vs. 83%) and in ≤mean/≤median (n=207/150) BAU groups vs. > mean/> median (n=92/149) BAU groups (95-97 vs. 82-85%). mOS and median PFS (mPFS) were higher for nal-IRI+5-FU/LV vs 5-FU/LV in all groups, with ≤ mean/≤ median BPI or BAU showing better outcomes vs. > mean/> median BPI or BAU (Table). Conclusions: BPI and BAU appear to have a prognostic effect on outcomes in mPDAC pts in the NAPOLI-1 study. No predictive effect was observed, with nal-IRI+5-FU/LV showing higher mOS vs. 5-FU/LV in all groups. Clinical trial information: NCT01494506. [Table: see text]

scholarly journals Nomogram for Predicting Survival in Patients Treated with Liposomal Irinotecan Plus Fluorouracil and Leucovorin in Metastatic Pancreatic Cancer

Cancers ◽  
2019 ◽  
Vol 11 (8) ◽  
pp. 1068 ◽  
Author(s):  
Chen ◽  
Macarulla ◽  
Blanc ◽  
Mirakhur ◽  
Jong ◽  
...  
Keyword(s):  
Carbohydrate Antigen ◽  
Phase Iii ◽  
Disease Stage ◽  
Ductal Adenocarcinoma ◽  
Karnofsky Performance Score ◽  
Neutrophil Lymphocyte Ratio ◽  
Baseline Factors ◽  
Liposomal Irinotecan ◽  
Aid Decision ◽  
Post Hoc

NAPOLI-1 (NCT01494506) was a phase III study of liposomal irinotecan (nal-IRI) plus 5-fluorouracil/leucovorin (5-FU/LV) in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) previously treated with gemcitabine-based therapy. This post hoc analysis of NAPOLI-1 aimed to develop a predictive nomogram for overall survival (OS) at 6 and 12 months. Analyses were derived from all patients in NAPOLI-1 randomized to receive nal-IRI+5-FU/LV, nal-IRI monotherapy, or 5-FU/LV combination therapy. OS was associated with baseline factors using univariate and multivariable Cox analyses. A predictive nomogram was derived and validated using a concordance index and calibration plots. The univariate analyses identified 21 independent factors that contributed to OS, with eight factors significantly associated with OS. The Karnofsky Performance Score contributed the largest number of points (100), followed by presence of liver metastasis (98) and randomization to nal-IRI+5-FU/LV (96). The other baseline factors showing effects were albumin (g/dL), neutrophil/lymphocyte ratio, carbohydrate antigen 19-9 (U/mL), disease stage at diagnosis, and body mass index (kg/m2). The nomogram was used to predict the 6- and 12-month survival probability. The mean absolute errors between the observed and predicted probabilities for OS at 3, 6, and 9 months were 0.07, 0.08, and 0.07, respectively. This nomogram, based on NAPOLI-1, provides additional insight to aid decision-making for patients with mPDAC after previous gemcitabine-based therapy.

Subgroup analysis by measurable metastatic lesion (ML) number and selected lesion locations (LL) at baseline (BL) in NAPOLI-1: A phase III study of liposomal irinotecan (nal-IRI)±5-fluorouracil/leucovorin (5-FU/LV) in patients (pts) with metastatic pancreatic ductal adenocarcinoma (mPDAC) previously treated with gemcitabine-based therapy.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 460-460
Author(s):  
Jens T. Siveke ◽  
Richard Hubner ◽  
Teresa Mercade Macarulla ◽  
Andrea Wang-Gillam ◽  
Andrew Peter Dean ◽  
...  
Keyword(s):  
Metastatic Lesion ◽  
Phase Iii ◽  
Ductal Adenocarcinoma ◽  
Pivotal Phase ◽  
Clear Trend ◽  
Prognostic Effect ◽  
Phase Iii Study ◽  
Previously Treated ◽  
Liposomal Irinotecan ◽  
Post Hoc

460 Background: We report a post hoc, exploratory analysis of pts with BL ML number and LL data who received nal-IRI+5-FU/LV, nal-IRI or 5-FU/LV in NAPOLI-1, a pivotal, phase 3 trial (NCT01494506). nal-IRI+5-FU/LV increased median OS (mOS) vs 5-FU/LV (6.1 vs 4.2 mo [HR=0.67; p=0.012]). Methods: ML (1, 2, 3, >3) and LL were recorded (local investigator) at BL. Pts with >1 LL were counted for each location. Results: 354 of 417 ITT pts had measurable BL ML and 1,080 LL were recorded. There was no clear trend in the percentage of pts with KPS ≥80 in 1- >3 ML (range 87%-95%) or LL (range 89%-94%) subgroups. ML 1 (n=81), 2 (n=65) and 3 (n=24) subgroups were small. nal-IRI+5-FU/LV significantly improved mOS vs. 5-FU/LV in pts with 2/>3 ML (n=184/24); nal-IRI+5-FU/LV had numerically higher mOS vs. 5-FU/LV for all LL (Table). nal-IRI+5-FU/LV had favourable median PFS (mPFS) vs. 5-FU/LV in pts with 1–>3 ML (range 2.0-4.2 vs. 1.4-1.9 mo; HR range 0.35-0.88) and for all LL (range 2.8-4.2 vs. 1.4-2.0 mo; HR range 0.39-0.55). Conclusions: Low pt numbers across groups and repeat counting of pts in LL subgroups preclude firm conclusions on treatment efficacy, pending further analyses. Allowing for these limitations, we detected no clear prognostic effect on outcomes of higher BL ML number or LL in NAPOLI-1 ITT pts. nal-IRI+5-FU/LV improved mOS vs. 5-FU/LV in some ML groups and across LL groups; improvement in mPFS vs. 5-FU/LV in the ITT population was maintained in all subgroups. Clinical trial information: NCT01494506. [Table: see text]

The Addition of Rituximab Eliminates the Negative Prognostic Impact of PMBCL Compared to DLBCL in Young Patients with CD20-Positive Aggressive Lymphomas Receiving a CHOP-Like Chemotherapy: Results of a Subgroup Analysis of the Mabthera International Trial Group (MInT) Study

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 839-839 ◽  
Author(s):  
Marek Trneny ◽  
Michael Rieger ◽  
Anders Osterborg ◽  
Ruth Pettengel ◽  
Darrell J White ◽  
...  
Keyword(s):  
Complete Remission ◽  
Subgroup Analysis ◽  
Young Patients ◽  
B Cell Lymphoma ◽  
Stage I ◽  
P Value ◽  
Prognostic Impact ◽  
Bulky Disease ◽  
Free Survival ◽  
The Impact

Abstract PMBCL is considered to be a distinct entity among diffuse large B-cell lymphoma (DLBCL). The optimal therapy is still matter of debate and the impact of the addition of rituximab to conventional chemotherapy is unknown. The aim of this subgroup analysis of the MInT study was to evaluate the effect of rituximab in PMBCL in comparison to other DLBCL with mediastinal involvement (mDLBCL). Eligible for the MInT study (Lancet Oncol2006; 7: 379–91) were patients aged 18–60 years with DLBCL who had 0–1 risk factors according to age-adjusted International Prognostic Index (IPI), stage II-IV disease, or stage I disease with bulk. Patients were randomly assigned to six cycles CHOP-like chemotherapy regimens with or without rituximab. Consolidating radiotherapy (30–40 Gy) was given to sites of primary bulky disease. Results: Of 824 patients enrolled, 87 had PMBCL and 139 mDLBCL according to nationally centralized hematopathologist review. 44 patients (51%) with PMBCL and 65 patients (47%) with mDLBCL were randomized to the rituximab arm. The subsets were balanced for IPI, but patients with PMBCL were younger (median age 35 vs 43 years); showed more frequently an elevated LDH (63% vs 33%), stage I/II disease (92% vs 65%) and bulky disease (85% vs 60%); and received more often mediastinal radiotherapy (69% vs 37%) compared with mDLBCL. Rituximab increased the rates of complete remission or complete remission unconfirmed (CR/CRu) in both subsets although this was statistically significant only for PMBCL (see Table). This was mainly due to the fact that in both subsets rituximab virtually eliminated progressive disease (PD) under primary treatment, whereas without rituximab, PD tended to be more frequent in PMBCL than in mDLBCL (24% vs 11%, p=0.09). With a median observation time of 37 months (range 0–59), estimated 3-year event-free-survival (EFS) was improved by rituximab for PMBCL (78% vs 52%, p=0.012), mDLBCL (74% vs 59%, p=0.130), and all other DLBCL (n=597, 80% vs 60%, p<0.0001). Rituximab also improved progression-free-survival (PFS) of PMBCL, but not of mDLBCL (Table). This could be explained in part by the favorable outcome of mDLBCL compared to PMBCL in the chemotherapy-only arm (3-year PFS 77% vs 64%, p=0.08). In both subsets, the overall survival (OS) benefit observed with rituximab did not reach statistical significance (Table). Multivariable cox regression models (adjusting for treatment arm; IPI; etoposide use (CHOEP21); bulky disease; histology (PBMCL vs mDLBCL); and the interactions between histology and treatment arm, and histology and IPI, respectively) identified rituximab as a strong prognostic factor and a trend to an interaction between histology and treatment arm for the outcome of a patient. Conclusion: In young patients with PMBCL, rituximab added to 6 cycles of CHOP-like chemotherapy increases response rate, EFS, and PFS to the same extent as in other DLBCL, thereby eliminating the outcome disadvantage of PMBCL observed with CHOP-like chemotherapy alone. PMBCL Rituximab CR/CRu PD 3y-EFS 3y-PFS 3y-OS No 54% (38%–70%) 24% (11%–38%) 52% (35%–66%) 64% (46%–77%) 78% (61%–88%) Yes 80% (68%–92%) 3% (0%–7%) 78% (61%–88%) 88% (70%–95%) 89% (71%–96%) P-value 0.03 0.006 0.012 0.006 0.16 mDLBCL Rituximab CR/Cru PD 3y-EFS 3y-PFS 3y-OS No 67% (55%–78%) 11% (3%–18%) 59% (46%–70%) 77% (64%–86%) 89% (79%–95%) Yes 81% (71%–91%) 2% (0%–5%) 74% (60%–83%) 81% (68%–89%) 92% (79%–97%) P-value 0.1 0.07 0.13 0.71 0.47

scholarly journals Subgroup analysis of patients with metastatic colorectal cancer (mCRC) treated with regorafenib (REG) in the CORRECT trial who had progression-free survival (PFS) longer than 4 months.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 710-710 ◽  
Author(s):  
Axel Grothey ◽  
Alfredo Falcone ◽  
Yves Humblet ◽  
Olivier Bouche ◽  
Laurent Mineur ◽  
...  
Keyword(s):  
Subgroup Analysis ◽  
Real Life ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Correct Trial ◽  
Multikinase Inhibitor ◽  
Biomarker Analysis ◽  
Common Grade ◽  
Grade 3 ◽  
Post Hoc

710 Background: In the CORRECT phase III trial (NCT01103323), the multikinase inhibitor REG significantly improved overall survival (OS) and PFS vs placebo in patients with mCRC who had disease progression after other standard therapies (HR for OS: 0.77; 1-sided p =0.0052; Grothey 2013). A post-hoc exploratory subgroup analysis was conducted to evaluate patients in the REG treatment group who had a PFS longer than 4 months (long-PFS) defined as patients who progressed, died, or discontinued treatment for other reasons after 4 months. Methods: Of the505 patients randomized to REG in CORRECT, 98 (19.4%) were classified as having a long-PFS benefit. Baseline characteristics, safety, and dosing parameters were analyzed descriptively. Results: The long-PFS subpopulation was representative of the overall study population (Table). Long-PFS patients received a median of 6 cycles of REG (1-12), 92% received ≥5 cycles, and 20% had > 8 cycles. Overall 34% of patients had dose reductions and 87% had dose interruptions. The actual mean daily dose was 139 mg and the mean percent of the planned dose was 81%. Adverse events (AE) of any grade were experienced by all long-PFS patients, and the most common grade ≥3 AEs were hand-foot skin reaction (20%), hypertension (17%), diarrhea (17%), and fatigue (16%). Conclusions: A subset of 98 (19.4%) patients treated with REG in the CORRECT study had a PFS > 4 months, confirming the clinical benefit and tolerability of REG as a treatment option for patients with mCRC. Prospective validation of these findings in conjunction with biomarker analysis from real-life clinical experience is needed. Clinical trial information: NCT01103323. [Table: see text]

Correlation of hand-foot skin reaction (HFS) with treatment efficacy in pancreatic cancer (PC) patients (pts) treated with gemcitabine/capecitabine plus erlotinib: A subgroup analysis from the AIO-PK0104 randomized, cross-over phase III trial in advanced PC.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 4023-4023
Author(s):  
Michael Haas ◽  
Stefan Hubert Boeck ◽  
Ruediger Paul Laubender ◽  
Dominik Paul Modest ◽  
Ursula Vehling-Kaiser ◽  
...  
Keyword(s):  
Treatment Failure ◽  
Subgroup Analysis ◽  
Locally Advanced ◽  
Skin Toxicity ◽  
Analysis Data ◽  
Phase Iii ◽  
Study Endpoint ◽  
Primary Study ◽  
Line Treatment ◽  
Phase Iii Trial

4023 Background: AIO-PK 0104 investigated the efficacy and safety of gemcitabine/erlotinib (G/E) followed by capecitabine (C) vs. C/E followed by G. The present subgroup analysis evaluated the correlation between C-associated skin toxicity and outcome parameters in PC. Methods: Within this multicenter phase III trial, pts with confirmed advanced PC were randomly assigned to 1st-line treatment with either C (2,000 mg/m2/d, d1-14 q d21) plus E (150 mg/d, arm A) or G (1,000 mg/m2 over 30 min weekly x 7, then d1, 8, 15 q d28) plus E (150 mg/d, arm B). A cross-over to either G (arm A) or C (arm B) was performed after treatment failure (e. g. disease progression or unacceptable toxicity). Time to treatment failure after 1st- and 2nd-line therapy (TTF2) was the primary study endpoint. Treatment-related skin toxicity was evaluated separately for each treatment arm/each regimen based on NCI-CTCv2. Results: Of 279 eligible pts, 47 had locally advanced, 232 had metastatic disease and 141 pts received second-line chemotherapy. For the present subgroup analysis data on skin toxicity were available from 255 pts. For the 73 pts (29%) with a HFS (any grade documented at any time during the treatment strategy), TTF2 and OS both were significantly prolonged compared to pts without HFS (7.4 vs 4.0 months, p<0.001 and 9.7 vs 5.5 months, p=0.002, respectively). Considering HFS during 1st-line treatment in 123 pts within the CE arm, these results could be confirmed for the 47 pts (38%) with a documented HFS of any grade (TTF2: 7.6 vs. 3.2 months, p<0.001; OS: 10.2 vs. 4.4 months, p=0.001). In pts receiving 1st-line treatment with G/E (n=132) no difference in outcome was observed for pts with (n=13) or without (n=119) HFS of any grade (TTF2: 5.7 vs. 4.2 months, p=0.375; OS: 8.4 vs. 6.6 months, p=0.505). Conclusions: The current subgroup analysis of AIO-PK0104 supports the assumption of a correlation between HFS in PC pts treated with capecitabine or capecitabine/erlotinib and efficacy endpoints like TTF2 and OS. A capecitabin-associated HFS thus might be predictive for efficacy in patients with advanced PC.

Characteristics of long-term survivors in a randomized phase III trial (NAPOLI-1) of patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) treated with liposomal irinotecan (nal-IRI; MM-398) + 5-FU/LV.

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 293-293
Author(s):  
Andrea Wang-Gillam ◽  
Chung-Pin Li ◽  
Gyorgy Bodoky ◽  
Andrew Dean ◽  
Kyung-Hun Lee ◽  
...  
Keyword(s):  
Liver Metastases ◽  
Performance Status ◽  
The United States ◽  
Small Sample ◽  
Phase Iii ◽  
Ductal Adenocarcinoma ◽  
Primary Analysis ◽  
Liposomal Irinotecan ◽  
Long Term Survivors

293 Background: nal-IRI, a liposomal formulation of irinotecan, plus 5-FU/LV is approved in the United States and Taiwan for patients (pts) with mPDAC previously treated with gemcitabine-based therapy. Primary analysis of the NAPOLI-1 trial (NCT01494506) showed that nal-IRI+5-FU/LV significantly improved median overall survival vs 5-FU/LV (6.1 vs 4.2 months; HR, 0.67; 95% CI, 0.49-0.92; P = 0.012; Wang-Gillam et al, Lancet. 2016). Herein we report baseline characteristics of pts surviving ≥1 year (data cutoff, Nov 2015). Methods: This analysis includes 117 pts assigned to treatment with nal-IRI 70 mg/m2 (free base) + 5-FU/LV 2400/400 mg/m2 q2w, and 119 pts assigned to treatment with 5-FU/LV 2000/200 mg/m2weekly for weeks 1-4 q6w. Results: A total of 29 (25%) pts in the nal-IRI+5-FU/LV arm and 17 (14%) in the 5-FU/LV arm survived ≥1 year. These pts typically had better performance status, lower CA19-9 (U/mL) levels, and were less likely to have liver metastases at baseline, compared with the overall population (Table). For long-term survivors in the nal-IRI+5-FU/LV arm, a higher proportion of pts had neutrophil-to-lymphocyte ratio (NLR) >5, a marker of poor prognosis, suggesting that higher NLR may potentially be predictive of survival outcome with nal-IRI+5-FU/LV. Conclusions: More pts receiving nal-IRI+5-FU/LV versus 5-FU/LV were alive beyond 1 year. The most prominent prognostic markers of survival ≥1 year included lower CA19-9, KPS ≥90 and absence of liver metastases. These analyses may be limited by small sample sizes. Clinical trial information: NCT01494506. [Table: see text]

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