EXPERT study: Randomized phase III trial of radical surgery and postoperative mFOLFOX6 versus perioperative mFOLFOX6 plus cetuximab in patients with KRAS wild-type resectable colorectal liver metastases (CLMs).

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 652-652 ◽  
Author(s):  
Yoshihiro Mise ◽  
Kiyoshi Hasegawa ◽  
Masaru Oba ◽  
Kensei Yamaguchi ◽  
Hiroyuki Uetake ◽  
...  
Keyword(s):  
Liver Metastases ◽  
Medical Information ◽  
Radical Surgery ◽  
University Hospital ◽  
Phase Iii ◽  
Wild Type ◽  
Phase Iii Trial ◽  
Significant Difference ◽  
Group A ◽  
Group B

652 Background: Up-front radical surgery and adjuvant chemotherapy were regarded as one of the standard-of-care (SOC) in patients with resectablecolorectal liver metastases (CLMs), while perioperative chemotherapy plus surgery is also accepted. We conducted a multicenter randomized phase III trial to compare radical surgery and post-operative mFOLFOX6 with peri-operative mFOLFOX6 plus cetuximab in patients with KRAS wild-type resectable CLMs. Methods: Patients who had KRAS wild-type resectable CLMs having one to eight liver nodules without extrahepatic disease, were randomly assigned to groups: Group A (reference), hepatectomy and 12 cycles of post-operative mFOLFOX6: Group B (experimental), six cycles of preoperative mFOLFOX6 plus cetuximab (loading dose with 400mg/m2and thereafter 250mg/m2weekly), hepatectomy and six cycles of postoperative mFOLFOX6 plus cetuximab. Primary endpoint was progression-free survival (PFS). We hypothesized that 3-year PFS in Group B would be 25% with the hazard ratio (HR) being 0.75. Considering 3 year follow-up period with 5% of two-sided alpha error and 80% of power, target number were set as 500 (250 each). Study was registered in the University Hospital Medical Information Network (UMIN000007787). Results: This study was initiated since June 2012. However, the enrollment was terminated according to the recommendation from the monitoring committee on 2015 due to a slow accrual. A total of 77 patients (Group A 37 vs. Group B 40) were analyzed. Baseline characteristics were well-balanced between groups. Median numbers of liver mets were two each, ranging from one to eight. The HRs for PFS and overall survival (OS) showed no significant difference (PFS, HR = 1.18 [0.69-2.01], p = 0.54: OS, HR = 1.03 [0.46 – 2.29], p = 0.95). There were 3-year PFS of 35% in Group A vs. 30% in Group B, and 3-year OS: 86% vs. 74%, respectively. Conclusions: No additional survival benefits adding on peri-operative cetuximab were indicated, of which findings is consistent with the previous clinical studies, although there were small number of enrolled patients. Clinical trial information: UMIN000007787.

A randomized phase II multi-institutional trial of anlotinib plus docetaxel versus docetaxel in EGFR-wild-type non-small cell lung cancer (NSCLC) patients after progression on first-line platinum-base chemotherapy: ALTER-L018.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e21703-e21703
Author(s):  
Lin Wu ◽  
Zhijun Wu ◽  
Zemin Xiao ◽  
Jie Weng ◽  
Zhongsha Ma ◽  
...  
Keyword(s):  
Advanced Nsclc ◽  
Phase Iii ◽  
Wild Type ◽  
First Line ◽  
End Points ◽  
Phase Iii Trial ◽  
Platinum Based Chemotherapy ◽  
Group A ◽  
Group B ◽  
Nsclc Patients

e21703 Background: Anlotinib is an oral VEGFR, FGFR, PDGFR and c-Kit tyrosine kinase inhibitor, which can prolong both PFS and OS of refractory advanced NSCLC patients in phase III trial: ALTER0303. The combination of docetaxel and ramucirumab/nintedanib had been demonstrated activity in the second line therapy setting for NSCLC. We performed ALTER-L018 to assessed the safety and efficacy of anlotinib with docetaxel in EGFR-wild type refractory advanced NSCLC (NCT03624309). Methods: Patients (pts) with EGFR-wild type refractory advanced NSCLC, who failed to first-line platinum-based chemotherapy, were randomized to group A(anlotinib: 12mg QD from day 1 to 14 of a 21-day cycle +docetaxel: 75mg/m2 Q3W) and group B(docetaxel: 75mg/m2 Q3W). The primary end points is PFS, and secondary end points include OS, ORR, DCR and safety. Results: Between January and December 2019, 36 pts were enrolled at 10 institutions in Hunan China, with 31(15 in group A, 16 in group B) of these individuals being evaluable for treatment efficacy and safety. Pt characteristics(group A/ group B): median age: 55(39-70)/57(44-67); male: 73%/81%; non-squamous NSCLC: 86%/75%. Median PFS were 5.3 months (95%CI:2.76-7.85) in group A and 2.3 months (95%CI, 1.14-3.46) in group B (HR 0.42; 95% CI:0.16-1.13; p = 0.047); In group A and B, ORR and DCR were 26.67% versus 0%(p = 0.043), 60.00% versus 31.25%(p = 0.16), respectively. Among 31 pts, 89% of treatment-related AEs (TRAEs) were grade 1 or 2, and the most common TRAEs in group A were hand-foot syndrome, pruritus and insomnia of 13%(2/15) each; in group B were alopecia, constipation and anemia of 12%(1/16) each. Toxicities≥grade 3(TRAEs) included: neutropenia, leukopenia, diarrhea and hrombocytopenia, 6.6%(1/15) each in group A. There was 1 grade 5 AE in group A. Conclusions: This combination of anlotinib and docetaxel with significant difference PFS prolonging and manageable safety profile, is a viable option in relapsed NSCLC, should be considered following progression on platinum-based chemotherapy. It will be further explored in a randomized phase III trial. Clinical trial information: NCT03624309.

A Comparative Study of Epidemiology, Clinicopathologic Features and Outcome of Colorectal Cancer Patients between Ain Shams University Hospitals and Luxor International Hospital

QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Tarek Hussein Kamel ◽  
Amr Lotfy Farag ◽  
Dr/Sherif Hassanin Ahmed ◽  
Chresteen Talaat Samy Hanna
Keyword(s):  
Colorectal Cancer ◽  
Comparative Study ◽  
Disease Free Survival ◽  
University Hospital ◽  
Treatment Modalities ◽  
Clinicopathologic Features ◽  
Free Survival ◽  
Significant Difference ◽  
Group A ◽  
Group B

Abstract Background Colorectal cancer (CRC) is one of the leading causes of mortality and morbidity in the world. It is the third most common malignancy after lung & breast and the fourth leading cause of cancer-related deaths worldwide, accounting for approximately 1,400,000 new cases and about 700,000 deaths worldwide. Objectives The aim of this retrospective study is to compare the epidemiology, clinicopathologic features, different treatment modalities and outcomes regarding disease free survival (DFS), progression free survival (PFS) & overall survival (OS) of colorectal cancer disease between cases presented to Ain shams university hospital & to Luxor international hospital in 3 consecutive years. Patients and Methods The study is retrospective comparative study. Clinical oncology department in Ain Shams University Hospital and Luxor International Hospital. The data Collected from January 2013 to December 2015. This study analyzed hospital records of patients who diagnosed with colorectal cancer (CRC) and allocated into two groups: Group A: CRC patients presented to Ain-Shams University Hospital from January 2013 to December 2015, group B: CRC patients presented to Luxor International Hospital from January 2013 to December 2015. Results There was no statistically significant difference regarding age parameter in LIH when compared to ASU, but the study was consistent with higher incidence in patients who were aged more than forty- accounted about 70.5% in all CRC cases. Cases less than 40 years old, in group A were 35.2%, while in Group B were 23.5%. Even there was no statistically significant difference but it may be attributable to more westernization in Lower Egypt. Other explanation may be due to decreased low socioeconomic status and different lifestyle factors in more developing region what increase risk of colorectal cancer. Among our cases, there is no statistically significant difference regarding gender between the two hospitals. Both sexes almost were affected equally, females appeared to be at a slightly higher risk of developing CRC cancer with current prevalence 1.3:1 in ASU group, and 1.1:1 in LIH group. Conclusion The need to increase awareness about CRC in Egypt especially upper Egypt, is recommended. An awareness campaign should be performed to promote detection of CRC at its earliest and most curable stage by recognizing early symptoms and enabling early referrals for colonoscopy. Those at higher risk should be offered more intensive surveillance. Similarity of the data from different centers suggests that this is the picture of colorectal cancer typical of Egypt.

The association of renal function with safety and efficacy of cisplatin plus S-1 (CS) therapy and docetaxel plus cisplatin plus S-1 (DCS) therapy in patients with advanced gastric cancer (AGC): An additional analysis of JCOG1013.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16035-e16035
Author(s):  
Shuichi Hironaka ◽  
Ryo Sadachi ◽  
Nozomu Machida ◽  
Satoru Iwasa ◽  
Yasuhide Yamada ◽  
...  
Keyword(s):  
Renal Function ◽  
Adverse Events ◽  
Objective Response ◽  
Exploratory Analysis ◽  
Phase Iii ◽  
Fixed Dose ◽  
Hematological Toxicity ◽  
Significant Difference ◽  
Group A ◽  
Group B

e16035 Background: A phase III study, JCOG1013, did not show the superiority of docetaxel plus cisplatin plus S-1 (DCS) to cisplatin plus S-1 (CS) in overall survival (OS) (Yamada Y, Lancet GH 2019). It is known that cisplatin and gimeracil (an inhibitor of dihydropyrimidine dehydrogenase contained in S-1) are excreted in urine. We previously reported (abstr 197, ASCO-GI 2021) exploratory analysis of JCOG1013 which showed creatinine clearance (CrCl) was associated with safety (Grade [G]4 hematological toxicity for CS, and G3-4 non-hematological toxicity for CS and DCS), but not with efficacy in either group. Here, we report the additional detail results of this exploratory analysis. Methods: Among 741 participants in JCOG1013, patients with serum creatinine level < 1.2 mg/dL were included in this analysis and categorized by CrCl and treatment into A1 (CrCl ≥ 80 mL/min, CS), A2 (60 < CrCl < 80, CS), A3 (CrCl < 60, CS), B1 (CrCl > 80, DCS), B2 (60 < CrCl < 80, DCS), and B3 (CrCl < 60, DCS). The dose (mg/m2) of C/S was 60/80 regardless renal function in group A (A1, A2 and A3), and that of D/C/S was adjusted in group B as follows: 40/60/80 in B1, 40/50/80 in B2, and 40/40/65 in B3. Adverse events, OS, progression-free survival (PFS), and objective response rate (ORR) were compared by CrCl in group A (A1 vs. A2 vs. A3) and group B (B1 vs B2 vs B3), respectively. Results: Of 723 pts (169/136/57 in A1/A2/A3 and 170/138/53 in B1/B2/B3), the median CrCl (mL/min) was 94.1/71.9/53.4 in A1/A2/A3 and 98.2/70.0/55.6 in B1/B2/B3. The relative dose intensity of C/S was 90.4/75.3%, 87.8/74.9% and 85.7/72.8% in A1, A2 and A3, and that of D/C/S was 87.5/77.7/74.9%, 85.8/61.2/72.7% and 87.8/49.4/58.3% in B1, B2 and B3. The incidence of G4 white blood cell decreased, G4 neutrophil count decreased, and G3-4 anorexia were 1.2/4.4/9.3% (P < 0.01), 4.8/11.1/18.5% (P < 0.01), 14.4/28.1/28.6% (P < 0.01) in A1/A2/A3, and 1.8/3.0/4.0% (P = 0.36), 27.3/24.8/20.0% (P = 0.28), 22.4/29.3/32.0% (P = 0.11) in B1/B2/B3, respectively. No significant association between CrCl and other adverse events was observed either in CS or in DCS group. The median OS was 15.4/15.5/15.4 months in A1/A2/A3 (P = 0.89) and 15.3/13.7/13.7 months in B1/B2/B3 (P = 0.72). The median PFS was comparable among A1/A2/A3 (7.1/6.8/6.2 months, P = 0.88) and B1/B2/B3 groups (7.5/7.2/7.8 months, P = 0.85). ORR showed no significant difference in A1/A2/A3 (58.9/57.8/46.9%, P = 0.31) and B1/B2/B3 groups (62.0/61.5/51.5%, P = 0.36). Conclusions: Dose modification according to renal function in the DCS arm could control the increase of severe toxicities, which were observed frequently in patients with low renal function in patients receiving fixed dose of CS. Clinical trial information: 000007652.

Safety and feasibility of laparoscopic surgery for colorectal cancer in elderly patients (YSURG1401 study).

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 725-725
Author(s):  
Yosuke Atsumi ◽  
Masakatsu Numata ◽  
Toru Aoyama ◽  
Tsutomu Hayashi ◽  
Naoto Yamamoto ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Laparoscopic Surgery ◽  
Elderly Patients ◽  
Surgical Outcomes ◽  
Operation Time ◽  
University Hospital ◽  
Age Group ◽  
Significant Difference ◽  
Group A ◽  
Group B

725 Background: The safety and feasibility of laparoscopic surgery (LAP) for colorectal cancer has not yet been fully evaluated in elderly patients. The aim of this study was to compare the short term surgical outcomes of LAP and evaluate the safety and feasibility of LAP in colorectal cancer patients aged > 75 years. Methods: This retrospective study enrolled consecutive patients who underwent laparoscopic surgery for colorectal cancer between April 2013 and March 2014 at Yokohama City University Hospital and its related general hospitals. The patients were categorized into two groups: elderly patients (≧75 years of age: group A) and non-elderly patients ( < 75 years of age: group B). Surgical outcomes and postoperative complications were compared between the two groups. The severity of complications was evaluated using the Clavien–Dindo classification. Results: A total of 237 patients were evaluated in the present study. Eighty-four patients were classified into group A, and 153 into group B. Preoperative clinicopathological outcomes demonstrated no significant differences except for the ASA score. When comparing the surgical outcomes between group A and group B, the rate of conversion to open procedure (3.6 % vs 5.2 %, P = 0.751), median operation time (232 min vs 232 min, P = 0.318), median blood loss (20 ml vs 12 ml, P = 0.353). There was no significant difference in the surgical outcomes. Although the incidence of Japanese D3 dissection was significantly lower in Group A (56 % vs 69.3 %, P = 0.047), the incidences of postoperative surgical complications of grade ≧ Ⅱ were similar between two groups (15.5 % vs 11.8 %, p = 0.427). The length of postoperative hospital stay was also similar (10days vs 10days, p = 0.347). Conclusions: The present study suggested that laparoscopic surgery for colorectal cancer is safe and feasible, regardless of the age of the patient, especially for elderly patients who may be candidates for colorectal cancer surgery.

mFOLFOXIRI with or without cetuximab as conversion therapy in patients with RAS/BRAF wild-type unresectable liver metastases colorectal cancer: The FOCULM study.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 99-99
Author(s):  
Huabin Hu ◽  
Kun Wang ◽  
Wei Wang ◽  
Meng Qiu ◽  
Rongbo Lin ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Liver Metastases ◽  
Wild Type ◽  
Conversion Therapy ◽  
Treatment Groups ◽  
Significant Survival ◽  
Secondary Endpoints ◽  
Group A ◽  
Unresectable Colorectal Liver Metastases ◽  
Group B

99 Background: Conversion therapy for unresectable colorectal liver metastases (LM) can downsize tumours and create a situation where the patient has no evidence of disease (NED). We assessed the effectiveness of cetuximab plus mFOLFOXIRI or mFOLFOXIRI in this setting. Methods: FOCULM was a prospective 2:1 controlled, multicenter, phase II trial. Given no free drugs offered and the patients' affordability for cetuximab, the study design has been amended from randomization to non-randomization since September, 2016. Patients with unresectable LM were assigned to receive cetuximab (500mg/m2) plus mFOLFOXIRI (oxaliplatin 85 mg/m2, irinotecan 165 mg/m2, folinic acid 400 mg/m2, 5-fluorouracil 2800mg/m2 46h infusion, every 2 weeks) (group A) or mFOLFOXIRI (group B). Primary endpoint was the rate of NED achieved, secondary endpoints were ORR, resection rate, the rate of local and ablative treatment (LAT), OS, PFS and DpR. Results: From February 2014 to July 2019, 114 patients were enrolled at 6 centers in China and 101 patients were in the ITT population (67 group A, 34 group B). Treatment groups were generally well balanced, although more patients with ≥5 LM were in group A. The rate of NED achieved was 62.7% in group A and 38.2% in group B (P = 0.020). At a median follow-up of 19.4 months, patients in group A had significantly prolonged the mOS, increased ORR, the rate of LAT and DpR compared with those in group B (Table). Patients with NED achieved yielded a significant survival benefit, whether in group A (Not reached vs. 49.4 months; P = 0.001) or group B (Not reached vs. 25.1 months; P = 0.007). Conclusions: The addition of cetuximab to a mFOLFOXIRI in patients with RAS/BRAF wild-type unresectable LM colorectal cancer significantly improved the rate of NED achieved, ORR and OS. Clinical trial information: NCT02063529. [Table: see text]

Assessment of Differences in Patient Populations Selected for or Excluded From Participation in Clinical Phase III Acute Myelogenous Leukemia Trials

2003 ◽  
Vol 21 (21) ◽  
pp. 3933-3939 ◽  
Author(s):  
Catherine Mengis ◽  
Stefan Aebi ◽  
Andreas Tobler ◽  
Werner Dähler ◽  
Martin F. Fey
Keyword(s):  
De Novo ◽  
Performance Status ◽  
Great Majority ◽  
Myelogenous Leukemia ◽  
University Hospital ◽  
Phase Iii ◽  
Trial Participation ◽  
Curative Intent ◽  
Phase Iii Trial ◽  
Significant Difference

Purpose: To compare patients treated in or outside clinical protocols, using de novo acute myeloid leukemia (AML) as a model disorder. Patients and Methods: We retrospectively compared the characteristics of all patients with de novo AML diagnosed in the referral area of our university hospital between 1985 and 1994. Results: Of a total of 170 AML patients, 45% were included in a phase III trial for the treatment of AML and 55% were treated outside a protocol. Another 45 patients were registered only at diagnosis but were treated elsewhere. Nonstudy patients differed significantly from patients included in clinical trials with respect to age and performance status at clinical presentation, comorbidity, and type of AML. The great majority of patients excluded from trial participation showed distinct exclusion criteria, such as advanced age and severe comorbidity. Study patients were treated significantly more often with curative intent and achieved better response and survival. Patients treated in an equivalent manner but outside a protocol showed no significant difference in survival compared with patients enrolled onto a trial. Conclusion: Study patients were not representative for the entire population of patients with AML; many patients were excluded from phase III trial participation for failure to meet stringent entry criteria. Therefore, results of phase III studies may not be extrapolated to all AML patients but should only be applied to patients who do not differ in substantial characteristics from the study population.

scholarly journals Outcome of thyroid lobectomies undergone with and without drains

2020 ◽  
Vol 8 (8) ◽  
pp. 2919
Author(s):  
Sahrish Bachani ◽  
Shahid N. Memon ◽  
Muhammad R. Pathan ◽  
Rehmat Sehrish Shah ◽  
Aneeta Kumari ◽  
...  
Keyword(s):  
Hospital Stay ◽  
Wound Infection ◽  
Pain Score ◽  
Thyroid Nodules ◽  
University Hospital ◽  
P Value ◽  
Thyroid Lobectomy ◽  
Significant Difference ◽  
Group A ◽  
Group B

Background: Thyroid lobectomy is a common operative technique of management of benign solitary thyroid nodules in which drains are used routinely. Objective of this study to compare the outcome of thyroid lobectomies undergone with and without drains in patients of benign solitary thyroid nodules.Methods: A comparative cross-sectional research was completed on 98 patients of benign solitary thyroid nodules at surgery department of Liaquat University Hospital Jamshoro. Patients having age of 18-60 years underwent thyroid lobectomies were included and distributed in two groups A and B. Group A includes thyroid lobectomies with drain and Group B without drain. Postoperative outcomes including pain score assessed via visual analog score (VAS), hospital stay and complications including wound infection, seroma and hematoma.Results: Out of 98 cases, 49 underwent thyroid lobectomy with drain and 49 without a drain. Females patients were in majority in group A 42 (85.7%) and also in group B 47 (95.9%). No significant difference (p-value=0.674) was in mean age of group A 30.8±10.2 years and group B 31.8±12.2 years. Higher mean with significant difference (p-value=0.001) was in pain score of group A 5.61±1.25 as compared to group B 3.55±0.70. No significant difference was in complications; seroma 1 (2.04%) vs 5 (10.20%), hematoma 1 (2.04%) vs 1 (2.04%) and infection 3 (6.12%) vs 0 (0.0%) in group A and B respectively. Higher mean with significant difference (p-value=0.001) was in hospital stay of group A 2.40±1.57 days as compared to group B 1.42±0.54 days. No significant difference (p-value=0.748) was in overall rate of complications in group A 5 (10.20%) and B 6 (12.24%).Conclusions: Thyroid lobectomy with drain is not effective in lowering the postoperative complications whereas enhanced the risk of postoperative pain, wound infection and duration of hospital stay as compared to thyroid lobectomy without a drain.

scholarly journals Clinical and Ultrasonographic Evaluation of the Pelvic Floor in Primiparous Women after Normal Vaginal Delivery with Episiotomy and without Episiotomy

2020 ◽  
Vol 7 (1) ◽  
pp. 4-8
Author(s):  
Nora H. K. Elabady ◽  
◽  
Ahmed M. Awara ◽  
Amr M. El-Badry ◽  
Nareman El-Hamamy ◽  
...  
Keyword(s):  
Pelvic Floor ◽  
Vaginal Delivery ◽  
Levator Ani ◽  
Clinical Findings ◽  
University Hospital ◽  
Normal Vaginal Delivery ◽  
Significant Difference ◽  
Group A ◽  
Group B ◽  
Primiparous Women

Objective The aim of this prospective study is clinical and ultrasonographic evaluation of the pelvic floor in primiparous women after normal vaginal delivery with episiotomy and without episiotomy. Methods This is a cross-section study of primiparous women with a history of delivery at Tanta University Hospital from August 2018 to August 2019. The sample power was calculated based on avulsion (major and minor) in two groups (vaginal delivery with episiotomy and without episiotomy) of total forty-primiparous women with an interval after delivery (20 cases after normal vaginal delivery with episiotomy and 20 cases after normal vaginal delivery without episiotomy). Results Twenty-four hours of delivery there was a highly significant difference between group A (with episiotomy) and group B (without episiotomy) regarding to ultrasound abnormalities, degree of tear, blood loss, hemoglobin concentration and clinical findings, while no difference regarding levator ani weakness. Two months later from delivery there was no significant difference between group A and group B regarding to ultrasound abnormalities and levator ani weakness while there was a difference between the two groups in regarding with clinical findings. Conclusion Normal vaginal delivery without episiotomy in primiparous women is better than normal vaginal delivery with episiotomy as there is no perineal tenderness, no dyspareunia. Low incidence of urinary, rectal incontinence, tear and perineal infection.

Assessment of Omentin- 1 AS AN Adipokine in obese male and females with and without fatty liver disease

QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Mohammed Ali Marei Makhlouf ◽  
Gina Gamal ◽  
Ahmad Magdy ◽  
Amal Muatafa Ali Mustafa Eid
Keyword(s):  
Fatty Liver ◽  
Protective Factor ◽  
University Hospital ◽  
Significant Difference ◽  
Hospital Patients ◽  
Group A ◽  
Group 2 ◽  
Group B ◽  
Obese Male ◽  
Control Study

Abstract Background Omentin-1 (intelectin-1) “a new adipokine described in 2003,” acts centrally to modulate the insulin resistance, body weight, and inflammation. However, its role in the liver pathogenesis and in the metabolic consequences of the liver disorders is not fully elucidated. Aim and objectives the aim of the study was to assess the relation of serum omentin1 with fatty liver in obese and non-obese Subjects and methods This was a comparative case control study was conducted at Ain Shams university hospital. Patients were divided in to two group: Group1: 40 patient 20 patient with fatty liver 10 of them obese and 10 non-obese compared with 20 not have fatty live 10obese and 10 non-obese, group 2. The duration of the study ranges from 6-12 months. Results There was statistically significant difference between the four studied subgroups as regard Omentin1 and Apelin. There was statistically significant difference between group A and group B in obese as regard Omentin1 and Apelin. Conclusion Omentin-1 might be considered as a protective factor in the evaluation of occurrence of NAFLD, especially in central obese patients. Thus, the measurement of these novel adipokines may contribute to the evaluation of NAFLD occurrence.

Randomized phase III clinical study comparing postoperative UFT/LV,UFT+LV/UFT and UFT+LV+PSK/UFT+PSK as adjuvant therapy for curatively resected stage III colorectal cancer HGCSG-CAD study.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 3638-3638
Author(s):  
Toshiaki Shichinohe ◽  
Yoshito Komatsu ◽  
Kohei Akazawa ◽  
Satoshi Yuki ◽  
Hiraku Fukushima ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Adverse Events ◽  
Gastrointestinal Symptoms ◽  
Phase Iii ◽  
Stage Iii ◽  
Lung Cancers ◽  
Fatigue Score ◽  
Significant Difference ◽  
Group A ◽  
Group B

3638 Background: Study showed that the oral anticancer agent UFT/LV is useful as postoperative adjuvant chemotherapy for stage III colorectal cancer. PSK, a protein-bound polysaccharide extracted from the mycelia of Coriolus versicolor, is an immunomodulator widely used in gastric, colorectal and lung cancers. Methods: Patients aged 20-80 years with stage III colorectal cancer registered in 35 facilities were randomized to: group A (UFT/LV 28 days/5 weeks for 6 months); group B (UFT+LV 28 days/5 weeks for 6 months, then UFT for 12 months); and group C (UFT+LV+PSK 28 days/5 weeks for 6 months, then UFT+PSK for 12 months). Treatment was started within 6 months after curative resection. Outcome measures were relapse-free survival (RFS), overall survival (OS), incidence and severity of adverse events, and QOL. Results: Of 342 patients registered, 340 eligible patients were analyzed (84 in group A, 85 in group B, and 171 in group C). At baseline, variation in QOL score was observed but histopathological parameters were not different among 3 groups. Median observation period was 36 months. 3-year RFS was 73.8%, 77.6% and 73.9% in groups A, B, and C [A vs C: hazard ratio (HR) 0.960, 95% confidence interval (CI) 0.575-1.601; B vs C: HR 0.837, CI 0.488-1.433; A vs B: HR 1.151, CI 0.623-2.126]. 3-year OS was 95.2%, 91.8% and 89.9% in groups A, B, and C (A vs C: HR 0.460, CI 0.155-1.367; B vs C: HR 0.814, CI 0.338-1.963 A vs B: HR 0.570, CI 0.167-1.947). Adverse events ≥grade 3 included gastrointestinal symptoms and general status. There was no treatment-related death. Excluding high fatigue score in QOL scale that showed pretreatment variation, stratification analysis showed interaction between family score and group, and efficacy was suggested especially in group C with high score (3-yesr RFS: 66.7%, 68.2% and 88.1% in groups A, B, and C. A vs C: HR 3.289, CI 0.951-11.375, B vs C: HR 3.070, CI 0.973-9.685, A vs B: HR 1.084, CI 0.344-3.417). Conclusions: A significant difference in primary endpoint was not detected. Variation in QOL at treatment initiation probably greatly affected outcome. Clinical trial information: NCT00209742.

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