scholarly journals FOLFIRINOX in patients with peritoneal carcinomatosis from pancreatic adenocarcinoma: a retrospective study

2019 ◽  
Vol 26 (4) ◽  
Author(s):  
E. Bonnet ◽  
C. Mastier ◽  
A. Lardy-Cléaud ◽  
P. Rochefort ◽  
M. Sarabi ◽  
...  
Keyword(s):  
Overall Survival ◽  
Peritoneal Carcinomatosis ◽  
Median Overall Survival ◽  
Group Performance ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Poor Prognostic Factor ◽  
Group 2 ◽  
Ecog Ps ◽  
Group 1

Background Peritoneal carcinomatosis (PCM) in metastatic pancreatic ductal adenocarcinomas (mPDAC) is frequently encountered in day-to-day practice, but rarely addressed in the literature. The objective of the present study was to describe the management and outcome of patients diagnosed with PCM.Methods Data for all consecutive patients with mpdac treated in our centre between 1 January 2014 and 31 August 2015 were analyzed retrospectively. Computed tomography imaging was centrally reviewed by a dedicated radiologist to determine the date of pcm diagnosis.Results The analysis included 48 patients. Median age in the group was 61 years, and 41 patients had an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0–1. All patients presented with pcm either synchronously (group 1) or metachronously (group 2). Those groups differed significantly by baseline ecog ps and neutrophil-tolymphocyte ratio (nlr), with ecog ps being poorer and nlr being higher in group 1. In addition to PCM, the main sites of metastasis were liver (62.5%) and lungs (31.3%). First-line chemotherapy in 36 patients (75%) was FOLFIRINOX (fluorouracil–irinotecan–leucovorin–oxaliplatin). The median overall survival for the entire population was 10.81 months [95% confidence interval (ci): 7.16 months to 14.16 months]; it was 13.17 months (95% ci: 5.9 months to 15.4 months) for patients treated with folfirinox. Median overall survival was 7.13 months (95% ci: 4.24 months to 10.41 months) for patients in group 1 and 14.34 months (95% ci: 9.79 months to 19.91 months) for patients in group 2, p = 0.1296.Conclusions Compared with other metastatic sites, synchronous pcm seems to be a poor prognostic factor. It could be more frequently associated with a poor ECOG PS and a NLR greater than 5 in this group of patients. In patients with mPDAC and PCM, either synchronous or metachronous, FOLFIRINOX remains an efficient regimen.

Real world eligibility of treatment-refractory stage IV colorectal cancer patients for palliative intent regorafenib monotherapy.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e15007-e15007 ◽  
Author(s):  
Arkhjamil Angeles ◽  
Wayne Hung ◽  
Winson Y. Cheung
Keyword(s):  
Colorectal Cancer ◽  
Overall Survival ◽  
Real World ◽  
Group Performance ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Stage Iv ◽  
Correct Trial ◽  
Eligibility Criteria ◽  
Ecog Ps

e15007 Background: The CORRECT trial demonstrated overall survival benefits of regorafenib monotherapy in patients with metastatic colorectal cancer (CRC) who were refractory to prior chemotherapy and biological therapy. However, stringent criteria used to determine treatment eligibility in the trial setting may limit its external validity in the real world. We aimed to examine treatment attrition rates and eligibility of regorafenib in routine clinical practice. Methods: All patients diagnosed with metastatic CRC between 2009 and 2014 who received 2 or more lines of systemic therapy at the British Columbia Cancer Agency were identified. During the study timeframe, cetuximab (cmab) and panitumumab (pmab) were only used in the chemo-refractory setting. Data on clinical factors, pathological variables and outcomes were ascertained and analyzed. Eligibility was defined based on criteria outlined in the CORRECT trial. Results: A total of 391 patients were included among whom only 39% were considered eligible for regorafenib. Median age was 61 (range 22-84) years. 247 (63%) were men, 305 (78%) were Caucasian, and 237 (60%) had a colonic primary. The disease burden at diagnosis was high: 267 (81%) had lymph node involvement, and 225 (59%) had distant metastases. In patients previously treated with cmab, main reasons for regorafenib ineligiblity were Eastern Cooperative Oncology Group performance status (ECOG PS) > 1 (26.9%), aspartate aminotransferase (AST) > 2 x upper limit of normal (ULN) (6.5%), and arterio-venous thrombotic or embolic events in the preceding 6 months (6.5%). In the group treated with pmab previously, main reasons for ineligibility were ECOG PS > 1 (46.6%), total bilirubin > 1.5 x ULN (14.1%), and thrombotic or embolic events in the past 6 months (5.7%). Additional analyses showed that regorafenib-eligible patients had increased median overall survival compared to ineligible patients (44.0 vs 37.1 months, P= 0.028). Conclusions: The strict trial eligibility criteria disqualified the majority of real world patients with metastatic CRC for regorfenib. As ineligibility predicts poorer outcomes, trials aimed at serving protocol-ineligible patients are warranted.

scholarly journals RARE-17. PRIMARY DIFFUSE LEPTOMENINGEAL GLIOMATOSIS OF HIGH GRADE TUMORS

2019 ◽  
Vol 21 (Supplement_6) ◽  
pp. vi225-vi225
Author(s):  
Ji-Eyon Kwon ◽  
Gyung-Oh Ko ◽  
Gi Hwan Hwang ◽  
In Ah Kim ◽  
Chan Woo Wee ◽  
...  
Keyword(s):  
Overall Survival ◽  
Median Overall Survival ◽  
Group Performance ◽  
Performance Status ◽  
Survival Rates ◽  
Eastern Cooperative Oncology Group ◽  
High Grade ◽  
Primary Diffuse Leptomeningeal Gliomatosis ◽  
Leptomeningeal Gliomatosis ◽  
Overall Survival Rates

Abstract Primary diffuse leptomeningeal gliomatosis(PDLG) of high grade glioma(HGG) is a rarely documented phenomenon observed in less than 5% of glioblastoma(GBM). Purposes of this study are to investigate the clinical outcomes of PDLG of HGG and to analyze the results according to the procedures of operations. We retrospectively reviewed the medical records of 469 patients of HGG at our institute between 2004 and 2019 and 9 of who with PDLG were enrolled in our study. These 9 patients satisfying the condition of Karnofsky performance status ≥70 and Eastern Cooperative Oncology Group performance status ≤2 were conducted the primary surgical biopsy with or without intracranial pressure control. All patients finished the surgery within about 11 days after the detection of leptomeningeal seeding(LMS) on preoperative MRI images and completed the concurrent chemoradiotherapy(CCRT) with temozolomide(TMZ). Among 9 patients, 7 patients started adjuvant temozolomide and 3 patients completed the six cycles of it. 7 patients had done ICP control operation such as ommaya reservoir insertion, extraventricular drainage, and ventriculoperitoneal shunt within 23.3 days after defined as PLDG and survived nearly 10 months. Their pathologic findings were turned out to be seven glioblastomas and two anaplastic astrocytomas. Their median overall survival was 14 months and the 1- and 2-year overall survival rates were 50.8±17.7% and 16.9±15%, respectively. Compared to the 10-year study of GBM in the same institute between 2004 and 2011, in which 67 patients finished with CCRT with TMZ, the median overall survival was 19 months and the 1- and 2-year overall survival rates were 78.3% and 41.7%. The results indicate that PLDG has a worse outcome and overall survival rate is lower than GBM without LMS, so the earlier start of standard CCRT right after aggressive control of increased ICP like conducting CSF diversion might be helpful for the elongation of life expectancy.

Complications following symptom-limited thoracentesis using suction

2020 ◽  
Vol 56 (5) ◽  
pp. 1902356 ◽  
Author(s):  
Ala Eddin S. Sagar ◽  
Maria F. Landaeta ◽  
Andres M. Adrianza ◽  
Grecia L. Aldana ◽  
Leonardo Pozo ◽  
...  
Keyword(s):  
Pleural Fluid ◽  
Group Performance ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Chest Discomfort ◽  
Mediastinal Shift ◽  
Increased Risk ◽  
Procedural Complications ◽  
Ecog Ps ◽  
Current Guidelines

BackgroundThoracentesis using suction is perceived to have increased risk of complications, including pneumothorax and re-expansion pulmonary oedema (REPO). Current guidelines recommend limiting drainage to 1.5 L to avoid REPO. Our purpose was to examine the incidence of complications with symptom-limited drainage of pleural fluid using suction and identify risk factors for REPO.MethodsA retrospective cohort study of all adult patients who underwent symptom-limited thoracentesis using suction at our institution between January 1, 2004 and August 31, 2018 was performed, and a total of 10 344 thoracenteses were included.ResultsPleural fluid ≥1.5 L was removed in 19% of the procedures. Thoracentesis was stopped due to chest discomfort (39%), complete drainage of fluid (37%) and persistent cough (13%). Pneumothorax based on chest radiography was detected in 3.98%, but only 0.28% required intervention. The incidence of REPO was 0.08%. The incidence of REPO increased with Eastern Cooperative Oncology Group performance status (ECOG PS) ≥3 compounded with ≥1.5 L (0.04–0.54%; 95% CI 0.13–2.06 L). Thoracentesis in those with ipsilateral mediastinal shift did not increase complications, but less fluid was removed (p<0.01).ConclusionsSymptom-limited thoracentesis using suction is safe even with large volumes. Pneumothorax requiring intervention and REPO are both rare. There were no increased procedural complications in those with ipsilateral mediastinal shift. REPO increased with poor ECOG PS and drainage ≥1.5 L. Symptom-limited drainage using suction without pleural manometry is safe.

Prognostic factors of ado-trastuzumab emtansine treatment in patients with metastatic HER-2 positive breast cancer

2020 ◽  
pp. 107815522092408 ◽  
Author(s):  
Deniz Tataroglu Ozyukseler ◽  
Mustafa Basak ◽  
Seval Ay ◽  
Aygül Koseoglu ◽  
Serdar Arıcı ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Group Performance ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Progression Free Survival ◽  
Trastuzumab Emtansine ◽  
Oncology Group ◽  
Cancer Antigen ◽  
Free Survival

Background Ado-trastuzumab emtansine is an antibody-drug conjugate that combines the cytotoxic activity of emtansine with human epidermal growth factor receptor 2-targeted antitumor features of trastuzumab. Objective We conducted a study of metastatic breast cancer patients treated with trastuzumab emtansine. By evaluating progression-free survival, overall survival, and response rates, we aimed to find prognostic factors of trastuzumab emtansine treatment. Methods Our study is a single-center, retrospective, observational study. We have clinical data from 78 patients treated with trastuzumab emtansine for metastatic breast cancer, from May 2016 through May 2019, at Kartal Dr Lutfi Kirdar Education and Research Hospital, Medical Oncology Department. Our objective is to assess the survival and response rates in trastuzumab emtansine-treated individuals and the factors associated with survival. The factors we analyzed were cancer antigen 15-3 sensitivity, Eastern Cooperative Oncology Group-Performance Status, presence or absence of visceral metastases, presence or absence of cranial metastases, and treatment-associated thrombocytopenia. Results Among 78 patients, median progression-free survival was 7.8 months, and overall survival was 21.1 months. Twenty of the patients had an objective tumor response. The results showed that trastuzumab emtansine was tolerable with a manageable safety profile and consistent with the results of the previous literature. Mostly seen adverse events were anemia, thrombocytopenia, fatigue, and increased levels of alkaline phosphatase. Patients with Eastern Cooperative Oncology Group-Performance Status = 2 had worse progression-free survival and overall survival compared to ones with Eastern Cooperative Oncology Group-Performance Status < 2; progression-free survival and overall survival are worse in cancer antigen 15-3-sensitive breast cancer patients. According to our findings, treatment-associated thrombocytopenia was a significant prognostic factor for survival. Patients with thrombocytopenia had 12 months progression-free survival, whereas patients without thrombocytopenia had only 4.1 months progression-free survival. In like manner, overall survival was much better in the thrombocytopenia-experienced patients as 29.5 versus 11.8 months. Conclusions Trastuzumab emtansine prolongs progression-free survival and overall survival with a manageable safety profile. Thrombocytopenia, Eastern Cooperative Oncology Group-Performance Status, and cancer antigen 15-3 are correlated with progression-free survival and/or overall survival.

Influence of tumor size and Eastern Cooperative Oncology Group performance status (ECOG PS) at baseline on patient (pt) outcomes in lenvatinib-treated radioiodine-refractory differentiated thyroid cancer (RR-DTC).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 6081-6081 ◽  
Author(s):  
Lori J. Wirth ◽  
Sophie Leboulleux ◽  
Naomi Kiyota ◽  
Makoto Tahara ◽  
Kei Muro ◽  
...  
Keyword(s):  
Tumor Size ◽  
Group Performance ◽  
Performance Status ◽  
Objective Response ◽  
Eastern Cooperative Oncology Group ◽  
Progression Free Survival ◽  
Disease Characteristics ◽  
Kaplan Meier ◽  
Ecog Ps ◽  
Post Hoc

6081 Background: In SELECT, lenvatinib significantly improved progression-free survival (PFS) of pts with RR-DTC versus placebo (18.3 v 3.6 months; hazard ratio [HR]: 0.21 [99% CI: 0.14, 0.31]; P<0.001). Here we examine the treatment of RR-DTC with lenvatinib in relation to tumor size (sum of all targeted lesions) and ECOG PS. Methods: In this post hoc analysis of SELECT with pts randomized to receive lenvatinib, Kaplan-Meier estimates of time to ECOG PS ≥2 were calculated for subgroups of pts according to baseline ECOG PS or tumor size. Objective response rate (ORR) and Kaplan-Meier estimates of overall survival (OS) and PFS according to ECOG PS (0 or 1) at baseline were calculated. Correlations between ECOG PS at baseline (0 or 1) and maximum tumor shrinkage were calculated using one-way analysis of variance. Results: Pts with ECOG PS 0 or 1 at baseline had similar demographic and disease characteristics. ORR was 78.5% and 51.0% for pts with ECOG PS 0 and 1 at baseline, respectively (odds ratio [95% CI]: 3.508 [2.018, 6.097]). Mean maximum percent decrease in tumor size was significantly greater in pts with baseline ECOG PS 0 (-46.13%) versus pts with ECOG PS 1 (-37.16%; P=0.0017). For pts with ECOG PS 1 at baseline, time to ECOG PS ≥2 was numerically shorter with tumor size >60 mm versus tumor size ≤60 mm (HR [95% CI]: 1.450 [0.708, 2.967]). Additional results are summarized in the table. Conclusions: Among pts with RR-DTC, PFS, OS, ORR, and time to ECOG ≥2 were generally better for patients with lower ECOG PS or smaller tumor size at baseline. These results may indicate that it is beneficial to start lenvatinib in pts with RR-DTC early, before ECOG PS worsens and tumor size increases. Clinical trial information: NCT01321554. [Table: see text]

scholarly journals Digital Detection of Sarcopenia in Pancreatic Cancer: Additional Utilization to Plan Patient Management

2021 ◽  
Author(s):  
Mustafa Jalal ◽  
Jennifer A Campbell ◽  
Jonathan Wadsley ◽  
Andrew D Hopper
Keyword(s):  
Skeletal Muscle ◽  
Pancreatic Cancer ◽  
Group Performance ◽  
Performance Status ◽  
Locally Advanced ◽  
Eastern Cooperative Oncology Group ◽  
Advanced Pancreatic Cancer ◽  
Skeletal Muscle Index ◽  
Ecog Ps ◽  
Cancer Network

Abstract Purpose: The presence of a sarcopenia adversely affects the prognosis of patients with pancreatic cancer. There is an emerging role for using computed tomography (CT) to calculate skeletal muscle index (SMI) and the presence of sarcopenia. The aim of this study was to assess if detecting ‘digital sarcopenia’ is feasible and can contribute to the management of patients with locally advanced pancreatic cancer (LAPC).Methods: Patients diagnosed with LAPC referred for endoscopic ultrasound guided biopsy (EUS-B) by our regional cancer network were identified. Age, body mass index (BMI), and Eastern Cooperative Oncology Group performance status (ECOG-PS) was noted. CT images were analysed for SMI and the presence of sarcopenia. Decision outcomes on receiving chemotherapy or not were collected from the regional oncology database. Results: In total 51/204 (25%) patients with LAPC who underwent EUS-B were not given chemotherapy and received BSC only. The prevalence of sarcopenia (p=0.0003), age ≥ 75 years old (p=0.03) and ECOG-PS 2-3 (p=0.01) were significantly higher in the patents receiving BSC only. Logistic regression analysis demonstrated that SMI was the only independent associated factor identifying patients with LAPC who were treated with BSC only and not chemotherapy after adjusting for age and ECOG-PS. Conclusion: Our study has shown that digital skeletal muscle analysis at the time of a diagnostic CT for patients with pancreatic cancer is feasible and can detect sarcopenia and malnourished patients who are much less likely to take up chemotherapy. These patients could be triaged to oncology assessment prior to EUS-B to avoid unnecessary investigations.

scholarly journals Nintedanib Plus Pemetrexed/Cisplatin in Patients With Malignant Pleural Mesothelioma: Phase II Results From the Randomized, Placebo-Controlled LUME-Meso Trial

2017 ◽  
Vol 35 (31) ◽  
pp. 3591-3600 ◽  
Author(s):  
Federica Grosso ◽  
Nicola Steele ◽  
Silvia Novello ◽  
Anna K. Nowak ◽  
Sanjay Popat ◽  
...  
Keyword(s):  
Overall Survival ◽  
Placebo Group ◽  
Phase Ii ◽  
Malignant Pleural Mesothelioma ◽  
Group Performance ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Phase Iii ◽  
Pleural Mesothelioma ◽  
Double Blind

Purpose LUME-Meso is a phase II/III randomized, double-blind trial designed to assess efficacy and safety of nintedanib plus chemotherapy as first-line treatment of malignant pleural mesothelioma (MPM). Phase II results are reported here. Patients and Methods Chemotherapy-naïve patients with unresectable, nonsarcomatoid MPM (Eastern Cooperative Oncology Group performance status 0 to 1), stratified by histology (epithelioid or biphasic), were randomly assigned in a 1:1 ratio to up to six cycles of pemetrexed and cisplatin plus nintedanib (200 mg twice daily) or placebo followed by nintedanib plus placebo monotherapy until progression. The primary end point was progression-free survival (PFS). Results Eighty-seven patients were randomly assigned. The median number of pemetrexed and cisplatin cycles was six; the median treatment duration for nintedanib was 7.8 months and 5.3 months for placebo. Primary PFS favored nintedanib (hazard ratio [HR], 0.56; 95% CI, 0.34 to 0.91; P = .017), which was confirmed in updated PFS analyses (HR, 0.54; 95% CI, 0.33 to 0.87; P = .010). A trend toward improved overall survival also favored nintedanib (HR, 0.77; 95% CI, 0.46 to 1.29; P = .319). Benefit was evident in epithelioid histology, with a median overall survival gain of 5.4 months (HR, 0.70; 95% CI, 0.40 to 1.21; P = .197; median [nintedanib v placebo], 20.6 months v 15.2 months) and median PFS gain of 4.0 months (HR, 0.49; 95% CI, 0.30 to 0.82; P = .006; median [nintedanib v placebo], 9.7 v 5.7 months). Neutropenia was the most frequent grade ≥ 3 adverse event (AE; nintedanib 43.2% v placebo 12.2%); rates of febrile neutropenia were low (4.5% in nintedanib group v 0% in placebo group). AEs leading to discontinuation were reported in 6.8% of those receiving nintedanib versus 17.1% of those in the placebo group. Conclusion Addition of nintedanib to pemetrexed plus cisplatin resulted in PFS improvement. AEs were manageable. The clinical benefit was evident in patients with epithelioid histology. The confirmatory phase III part of the study is ongoing.

Influence of Eastern Cooperative Oncology Group performance status (ECOG PS), tumor size and age on patient outcomes after anlotinib treatment: A subgroup analysis based on ALTER01031 trial for medullary thyroid carcinoma (MTC).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 6527-6527
Author(s):  
Ming Gao ◽  
Yihebali Chi ◽  
Xiangqian Zheng ◽  
Dapeng Li ◽  
Pingzhang Tang ◽  
...  
Keyword(s):  
Functional Status ◽  
Tumor Size ◽  
Group Performance ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Age Groups ◽  
Disease Stage ◽  
Lesion Diameter ◽  
Tumor Lesion ◽  
Ecog Ps

6527 Background: Anlotinib is a newly developed TKI achieved a nearly 2-fold PFS prolongation in a randomized, placebo-controlled phase 2b trial (NCT02586350) for MTC, the results of which were firstly published in 2019 ASCO annual meeting. This subanalysis examined the influence of baseline demographic (ECOG PS score, age) and tumor size on efficacy in this study. Methods: Kaplan-Meier method was applied to estimate the median PFS (mPFS) for subgroups of patients (pts) received anlotinib or placebo based on ECOG PS score (0 vs. 1), median tumor lesion diameter ( < 67 vs. ≥67mm) and age ( < 55 vs. ≥55 years old). Results: 91 eligible pts were randomly assigned in a 2:1 ratio to receive anlotinib or placebo. The numbers of pts in each subgroup were summarized in the table below. In placebo arm, mPFS did not differ significantly between pts with ECOG PS 0 and 1 (11.3 vs. 11.1months; HR = 0.895 [95% CI 0.347, 2.312], P = 0.821) or between pts with tumor lesion diameter < 67mm and ≥ 67mm (7.0 vs. 11.1 months; HR = 1.168 [95% CI 0.463, 2.945], P = 0.737). Conversely, pts in anlotinib arm with ECOG PS 0 obtained more PFS benefits (34.6 vs. 14.0 months; HR = 0.331 [95% CI 0.163, 0.671], P = 0.002). Similarly, anlotinib treated pts with tumor lesion diameters < 67mm achieved a longer mPFS (Not reached vs. 14.0 months, HR = 0.567 [95% CI 0.280, 1.147], P = 0.111). Consistent with that has been verified in differentiated thyroid cancer, high age predicted poor prognosis as mPFS were 14.3 months and 6.8 months in pts < 55 and ≥ 55 years old respectively in placebo arm (HR = 0.322 [95% CI 0.116, 0.893], P = 0.007).). Anlotinib treatment exhibited PFS improvement to pts in both age groups but higher PFS prolongation was observed in pts < 55 years old (22.4 vs. 14.0 months; HR = 0.720 [95% CI 0.321, 1.614], P = 0.381). Conclusions: This analysis showed that for pts in placebo arm, PFS was similar regardless of functional status (ECOG PS) or tumor size while older pts had higher progression risk. Treatment with anlotinib exhibited greater PFS benefits for pts with better functional status (ECOG PS = 0), younger age or lower tumor burden. These results indicated that it is reasonable to start anlotinib treatment at a relative earlier disease stage before the worsen of ECOG PS, increase of tumor size or ageing. Clinical trial information: NCT02586350 . [Table: see text]

A multicenter clinical randomized phase II study of investigating duration of adjuvant chemotherapy with S-1 (six versus 12 months) for patients with resected pancreatic cancer: PACS-1 study.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 669-669
Author(s):  
Yo-ichi Yamashita ◽  
Shinji Itoh ◽  
Mototsugu Shimokawa ◽  
Hiroshi Takamori ◽  
Kengo Fukuzawa ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Survival Rate ◽  
Adjuvant Chemotherapy ◽  
Median Overall Survival ◽  
Group Performance ◽  
Eastern Cooperative Oncology Group ◽  
Progression Free Survival ◽  
Rank Test ◽  
Overall Survival Rate

669 Background: Although adjuvant chemotherapy with S-1 has improved overall survival and progression-free survival (PFS) in patients with resected pancreatic cancer, the duration evaluation of adjuvant chemotherapy with S-1 have not established yet. Methods: We did a randomized, multicenter, phase 2 trial undertaken at 15 hospitals in Japan. Patients who were Eastern Cooperative Oncology Group performance states of 0 or 1 and aged 20 years or older were eligible. Patients with resected pancreatic cancer were randomly assigned (in a 1:1 ratio) to receive S-1 [40 mg, 50 mg, or 60 mg according to body-surface area, orally administered twice a day for 28 days followed by a 14 day rest, every 6 weeks [one cycle], for up to four cycles (6 months)] or up to eight cycles (12 months). The primary end point was overall survival rate. Secondary endpoints included PFS and safety. Results: The population consisted of 82 patients in the S-1 for 6 months group and 82 patients in the S-1 for 12 months group. The 2-year overall survival rate was 71.4% in the S-1 for 6 months group and 65.4% in the S-1 for 12 months, and the median overall survival was 31.0 months in the S-1 for 6 months group and 26.3 months in the S-1 for 12 months group [hazard ratio (HR) 1.23, 95% confidence interval (CI) 0.76-1.99, p = 0.377]. The PFS at 2 years was 56.8% in the S-1 for 6 months group, and 51.2% in the S-1 for 12 months. The HR for recurrence of S-1 for 6 months, compared with S-1 for 12 months, was 1.23 (95%CI 0.76-1.99, p = 0.392). Twenty-nine (35.3%) patients in the S-1 for 6 months group and 46 (56.0%) in the S-1 for 12 months group discontinued treatment before completion. In regard to patients completed treatment, the S-1 for 12 months group showed tendency to favorable prognosis on PFS compared with the S-1 for 6 months group (log-rank test; p = 0.175). Conclusions: In patients with resected pancreatic cancer, adjuvant chemotherapy with S-1 for 12 months is not superior to that for 6 months in terms of median overall survival and PFS. For patients who can tolerate adjuvant chemotherapy with S-1 for 6 months well, continuing treatment for up to 12 months may improve the prognosis.

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