scholarly journals Nivolumab in previously treated advanced gastric cancer (ATTRACTION-2): 3-year update and outcome of treatment beyond progression with nivolumab

2021 ◽  
Author(s):  
Narikazu Boku ◽  
Taroh Satoh ◽  
Min-Hee Ryu ◽  
Yee Chao ◽  
Ken Kato ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Placebo Group ◽  
Survival Rate ◽  
Advanced Gastric Cancer ◽  
Complete Response ◽  
Treatment Groups ◽  
Term Efficacy ◽  
Treatment Beyond Progression

Abstract Background ATTRACTION-2 demonstrated that nivolumab improved overall survival (OS) vs placebo in patients with advanced gastric cancer treated with ≥ 2 chemotherapy regimens. However, its long-term efficacy and outcome of treatment beyond progression (TBP) with nivolumab have not been clarified. Methods The 3-year follow-up data were collected. A subset analysis was performed to explore the efficacy of TBP by assessing postprogression survival (PPS) after the first event of disease progression. Results Overall, 493 patients were randomized (2:1) to receive nivolumab (n = 330) or placebo (n = 163). With a median follow-up of 38.5 (range 36.1–47.5) months, OS of the nivolumab group was significantly longer compared to the placebo group (median 5.3 vs 4.1 months; 3-year survival rate, 5.6% vs 1.9%; hazard ratio [HR], 0.62 [95% confidence interval (CI) 0.50–0.75], P < 0.0001). The median OS of responders (n = 32) who achieved complete response or partial response was 26.7 months and the 3-year survival rate was 35.5% in the nivolumab group. Overall, 109 patients in the nivolumab group and 37 patients in the placebo group received TBP. PPS tended to be longer in the nivolumab group vs placebo group (median 5.8 vs 4.5 months; HR [95% CI], 0.69 [0.47–1.01], P = 0.057). In contrast, PPS was similar between both treatment groups in non-TBP patients (median 2.3 vs 2.2 months; HR 0.90, P = 0.42). Conclusions Long-term efficacy of nivolumab was confirmed at the 3-year follow-up, and a survival benefit of TBP with nivolumab was suggested. Biomarkers for selecting patients suitable for TBP with nivolumab should be identified in the future.

Feasibility study of TAS-118 plus oxaliplatin as perioperative chemotherapy for patients with locally advanced gastric cancer (APOLLO-11).

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 205-205
Author(s):  
Daisuke Takahari ◽  
Manabu Ohashi ◽  
Atsuo Takashima ◽  
Takuro Mizukami ◽  
Naoki Ishizuka ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Locally Advanced ◽  
Dose Intensity ◽  
Complete Response ◽  
Free Survival ◽  
D2 Gastrectomy ◽  
Locally Advanced Gastric Cancer ◽  
Grade 3

205 Background:TAS-118 (S-1 and leucovorin) + oxaliplatin (L-OHP) improved overall survival (OS) compared to S-1 + cisplatin for patients (pts) with advanced gastric cancer (GC) (Kang, Lancet Oncol. 2020). This study investigated the feasibility of peri (pre and post)-operative (op) chemotherapy (chemo) with TAS-118 ± L-OHP in pts with locally advanced resectable GC. While it was reported that pre-op TAS-118 + L-OHP followed by D2 gastrectomy was well tolerated and showed promising efficay (Takahari, ASCO-GI. 2020), the recommended post-op chemo regimen, TAS-118 or TAS-118 + L-OHP, has yet to be determined. Methods:Eligible pts with GC of clinical T3-4N1-3M0 were enrolled. The protocol treatment consisted of pre-op chemo with 4 courses of TAS-118 (40-60 mg/body, orally, twice daily, 7 days) + L-OHP (85 mg/m2, intravenously, day 1) in a 2-week cycle, and gastrectomy with D2 lymphadenectomy, followed by post-op chemo with 12 courses of TAS-118 (step 1) and 8 courses of TAS-118 + L-OHP (step 2). Step 2 was started if the dose-limiting toxicity (DLT) occurred in < 6 of 10 pts in step 1. Up to 20 pts were included in the analysis of feasibility after a recommended regimen was determined. Results:Between December 2016 and February 2019, 45 pts were enrolled. The numbers of pts with cT3/4a and cN1/2/3 were 13/32 and 25/17/3, respectively. Excluding 14 pts (4 achieving pathological complete response, 4 not satisfying the criteria for post-op chemo, 3 physician judgement or pt withdrawal, 2 progressive disease, 1 adverse event [AE]), 31 pts (11/20 in step 1/2) received the post-op chemo. No DLT was observed in either step. The post-op chemo completion rate was 90.9% (95% CI, 63.6-99.5) in step 1 and 80.0% (95% CI, 59.9-92.9) in step 2. The median relative dose intensity of TAS-118 in step 1 was 83.3%, and those of TAS-118 and L-OHP in step 2 were 69.9% and 74.3%, respectively. One pt in step 2 discontinued post-op chemo due to AE. Grade ³ 3 AEs observed in ≥ 10% of pts were weight loss in both step 1 and step 2 (2 in each), and hypokalemia (n = 3) and neutropenia (n = 2) in step 2. At 1-year follow-up after the last pt was enrolled, recurrence-free survival and OS rates were 91.1% (95% CI, 78.0-96.6) and 100%, respectively at 12 months, and 69.1% (95% CI, 49.6-82.3) and 95.5% (95% CI, 71.9-99.3), respectively at 24 months. Conclusions:Taken together with the feasibility and efficacy of pre-op chemo, peri-op chemo with TAS-118 + L-OHP with D2 gastrectomy was well tolerated and showed promising efficacy. Clinical trial information: UMIN000024688.

scholarly journals Mid- and long-term efficacy of surgical treatment of Vancouver B2 and B3 periprosthetic femoral fractures

BMC Surgery ◽  
2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Jian-Ning Sun ◽  
Yu Zhang ◽  
Ye Zhang ◽  
Jia-Ming Zhang ◽  
Xiang-Yang Chen ◽  
...  
Keyword(s):  
Surgical Treatment ◽  
Survival Rate ◽  
Femoral Fractures ◽  
First Year ◽  
Femoral Prosthesis ◽  
Term Efficacy ◽  
Kaplan Meier ◽  
Sf 36

Abstract Background The incidence of fractures around the femoral prosthesis among patients undergoing hip arthroplasty is increasing and has become the third leading cause of hip revision. While numerous methods for the surgical treatment of periprosthetic femoral fractures (PFFs) have been proposed, only few reports have examined the long-term efficacy of surgical treatment. This study aims to examine the mid-and long-term efficacy of surgical treatment among patients with Vancouver B2 and B3 PFFs. Methods This retrospective study evaluated the surgical outcomes of patients with Vancouver B2 and B3 PFFs between 2007 and 2011. The minimum follow-up time was eight years. Fracture healing, prosthesis stability, complications, patient quality of life SF-36 score, and survival rate were evaluated during the follow-up assessments. Results A total of 83 patients were included and had an average follow-up period of 120.3 months. Among these patients, 69 were classified as Vancouver B2 and were treated with a distal fixation stem, whereas 14 cases were classified as Vancouver B3 and were treated with modular femoral prosthesis by using a proximal femoral allograft technique. A total of 15 patients underwent secondary revision surgery, and prosthesis dislocation was identified as the main cause of secondary revision. 80 (96.4%) cases of fractures were clinically healed. The mortality rate in the first year after surgery was 8.4% (7/83). The overall 5-year Kaplan–Meier survival rate for these patients was 75.9%. Meanwhile, the 5-year Kaplan–Meier survival rate for the implants was 86.9%. The final follow-up SF-36 score of the patients was 48.3 ± 9.8. Conclusions Patients with Vancouver B2 and B3 PFFs show high mortality in the first year after their surgery, and the Kaplan–Meier analysis results showed that such mortality tends to plateau after 5 years. Prosthesis dislocation was identified as the primary cause of secondary revision.

scholarly journals Long Term Effectiveness of Photodynamic Therapy for CIN Treatment

2019 ◽  
Vol 12 (3) ◽  
pp. 107 ◽  
Author(s):  
Natalia Mayumi Inada ◽  
Hilde Harb Buzzá ◽  
Marieli Fernanda Martins Leite ◽  
Cristina Kurachi ◽  
Jose Roberto Trujillo ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Photodynamic Therapy ◽  
Placebo Group ◽  
Cervical Intraepithelial Neoplasia ◽  
Intraepithelial Neoplasia ◽  
Complete Response ◽  
Incidence Rates ◽  
South Central

(1) Background: Cervical cancer is the third most commonly diagnosed cancer and the fourth leading cause of cancer death in women worldwide. The highest incidence rates are in Africa, followed by South-Central Asia and South America. According to the Brazilian National Institute of Cancer (INCA), 16,370 new cases of cervical cancer were estimated for each year of the biennium of 2018–2019. About 90% of cervical cancers originate from the malignant progression of cervical intraepithelial neoplasia (CIN) which is classified based on cytohistological characteristics (low- and high-grade lesions). The present study reports the long-term effectiveness of topical photodynamic therapy (PDT) for CIN grades 1 and 2/3 with up to two years of follow up. (2) Methods: A total of 56 patients with CIN 1, ten with CIN 2, and 14 patients for the placebo group were enrolled in this study. (3) Results: 75% (n = 42) of CIN 1 patients presented a complete response to PDT and only 23.2% (n = 13) of recurrence, progression, and/or lesions remaining two years after PDT. For CIN 2/3 patients, 90% were observed to be cured after one and two years of follow up. (4) Conclusions: PDT presented best results two years after a non-invasive, fast, and low-cost procedure and in comparison with the placebo group, preventing the progression of cervical intraepithelial neoplasia and preserving the cervix.

Long-term outcome of laparoscopic versus open total gastrectomy for advanced gastric cancer: A propensity score-matched analysis.

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 77-77
Author(s):  
Hayemin Lee ◽  
Junhyun Lee
Keyword(s):  
Gastric Cancer ◽  
Lymph Node ◽  
Survival Rate ◽  
Propensity Score ◽  
Advanced Gastric Cancer ◽  
Total Gastrectomy ◽  
Term Survival ◽  
Long Term Outcome ◽  
Open Total Gastrectomy

77 Background: Laparoscopic total gastrectomy (LTG) for advanced gastric cancer (AGC) is technically and oncologically challenging procedure for surgeons. The aim of this study is to compare technical safety and long-term oncologic feasibility of LTG for AGC patients compared to open total gastrectomy (OTG) using propensity score (PS)-matched analysis. Methods: Between 2004 and 2014, 185 patients (OTG: 127, LTG: 58) underwent total gastrectomy due to advanced gastric cancer. PS-matching was done using patients’ age, sex, American Society of Anesthesiologist (ASA) physical status, extent of lymph node dissection, presence of combined resection and pathological stage of gastric cancer. Comparisons were made based on surgical outcomes and long-term survival rates. Results: After PS-matching, 102 patients, respectively 51 patients for each group, were enrolled. LTG had longer tumor-free proximal resection margin (OTG 2.5 cm vs. LTG 3.0 cm, p = 0.008). Total number of retrieved lymph node and metastasized lymph node was similar in both groups. The retrieved number of lymph nodes around splenic hilum (#10 and #11d) was similar in both groups (p = 0.105). Longer operation time was required in LTG (OTG 240 min. vs. LTG 320 min, p = 0.002) but less intraoperative bleeding was observed in LTG (OTG 390 cc vs. LTG 276 cc, p < 0.001). Patients of LTG were discharged earlier than OTG (OTG 12 days vs. LTG 10 days, p = 0.043). Overall morbidity and mortality of both group was similar. Between two groups, there was not a difference in 5-year overall survival rate (OTG 56.3% vs. LTG 56.5%, p = 0.597) or disease free survival rate (OTG 59.0% vs. LTG 67.6%, p = 0.455). Conclusions: For treating proximal AGC, LTG may be a technically and oncologically safe and feasible method.

scholarly journals Laparoscopic gastrectomy for stage II and III advanced gastric cancer: long‑term follow‑up data from a Western multicenter retrospective study

2021 ◽  
Author(s):  
Umberto Bracale ◽  
Giovanni Merola ◽  
Giusto Pignata ◽  
Jacopo Andreuccetti ◽  
Pasquale Dolce ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Lymph Nodes ◽  
Advanced Gastric Cancer ◽  
Laparoscopic Gastrectomy ◽  
Postoperative Morbidity ◽  
Stage Ii ◽  
Long Term Results ◽  
The Mean

Abstract Introduction There has been an increasing interest for the laparoscopic treatment of early gastric cancer, especially among Eastern surgeons. However, the oncological effectiveness of Laparoscopic Gastrectomy (LG) for Advanced Gastric Cancer (AGC) remains a subject of debate, especially in Western countries where limited reports have been published. The aim of this paper is to retrospectively analyze short- and long-term results of LG for AGC in a real-life Western practice. Materials and methods All consecutive cases of LG with D2 lymphadenectomy for AGC performed from January 2005 to December 2019 at seven different surgical departments were analyzed retrospectively. The primary outcome was diseases-free survival (DFS). Secondary outcomes were overall survival (OS), number of retrieved lymph nodes, postoperative morbidity and conversion rate. Results A total of 366 patients with stage II and III AGC underwent either total or subtotal LG. The mean number of harvested lymph nodes was 25 ± 14. The mean hospital stay was 13 ± 10 days and overall postoperative morbidity rate 27.32%, with severe complications (grade ≥ III) accounting for 9.29%. The median follow-up was 36 ± 16 months during which 90 deaths occurred, all due to disease progression. The DFS and OS probability was equal to 0.85 (95% CI 0.81–0.89) and 0.94 (95% CI 0.92–0.97) at 1 year, 0.62 (95% CI 0.55–0.69) and 0.63 (95% CI 0.56–0.71) at 5 years, respectively. Conclusion Our study has led us to conclude that LG for AGC is feasible and safe in the general practice of Western institutions when performed by trained surgeons.

scholarly journals A Case of Advanced Gastric Cancer in Which Complete Response was Confirmed with Resection Following Long-term TS-1/CDDP Combined Chemotherapy

2006 ◽  
Vol 39 (1) ◽  
pp. 38-43 ◽  
Author(s):  
Takaaki Sugiki ◽  
Tatsuo Inoue ◽  
Emiko Yanatori ◽  
Hirotaka Kamikozuru ◽  
Hidetoshi Oguma ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Complete Response ◽  
Combined Chemotherapy

Update of AMC 0201 study: A randomized phase III trial comparing mitomycin-C plus short-term doxifluridine (Mf) versus mitomycin-C plus long-term doxifluridine plus cisplatin (MFP) after curative resection of advanced gastric cancer (NCT00296335).

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 76-76 ◽  
Author(s):  
Baek-Yeol Ryoo ◽  
Yoon-Koo Kang ◽  
Young Joo Min ◽  
Dae Young Zang ◽  
Gyu Yeol Kim ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Adjuvant Chemotherapy ◽  
Advanced Gastric Cancer ◽  
Mitomycin C ◽  
Phase Iii ◽  
R0 Resection ◽  
Long Term Follow Up ◽  
Asco Meeting

76 Background: Despite a continuing debate on the role of adjuvant chemotherapy, several studies have suggested that mitomycin-C (M) plus fluoropyrimidine (f) could improve the outcome of curatively resected advanced gastric cancer (AGC) patients (pts). To improve further the adjuvant Mf chemotherapy, we have prolonged the administration of oral fluoropyrimidine (F) and added cisplatin (P) to Mf (MFP) and performed a phase III randomized trial to determine whether this strategy could improve the 3-year relapse free survival (3yRFS) in curatively resected AGC pts (HR=0.63, α=0.05, β=0.1). Three year follow-up results were reported in 2008 ASCO meeting. Here we report long-term follow-up results for confirmation. Methods: Three to 6 wks after R0 resection, the pts who had postoperative stage II-IV were randomized to receive either Mf or MFP adjuvant chemotherapy. For Mf group, 20 mg/m2 of M was iv injected and 4 wks later, 460-600 mg/m2/day of doxifluridine was administered orally for 3 months. For MFP group, the administration of doxifluridine was extended for a total of 12 months and 6 shots of monthly 60 mg/m2 of cisplatin were added to Mf. Results: Between Feb 2002 and Aug 2006, a total of 871 pts were randomized (435 in Mf, 436 in MFP). Sixteen pts were excluded because of ineligibility (11 in Mf, 5 in MFP). Postoperative stages were II in 51.0%, IIIA in 31.1%, IIIB in 9.4%, and IV in 8.5% of pts. With a median follow up of 6.6 yrs in April 2011, a total of 353 events (relapse or death) have been observed. There was no difference in RFS between the two groups (HR, 1.10; 95% C.I. 0.89 – 1.35; p=0.3918; 5yRFS 61.1% in Mf and 57.9% in MFP). Difference in overall survival (OS) was also insignificant (HR, 1.11; 95% C.I. 0.89 – 1.39; p=0.3349; 5yOS 66.5% in Mf and 65.0% in MFP). Conclusions: Long-term follow-up results of AMC 0201 trial confirmed prolongation of doxifluridine administration and addition of cisplatin to adjuvant chemotherapy with mitomycin-C plus 3 months of doxifluridine did not improve the treatment outcome in curatively resected AGC pts.

Mid- and long-term efficacy of surgical treatment of Vancouver B2 and B3 periprosthetic femoral fractures

2020 ◽  
Author(s):  
Jian-Ning Sun ◽  
Yu Zhang ◽  
Ye Zhang ◽  
Jia-Ming Zhang ◽  
Xiang-Yang Chen ◽  
...  
Keyword(s):  
Surgical Treatment ◽  
Survival Rate ◽  
Femoral Fractures ◽  
First Year ◽  
Femoral Prosthesis ◽  
Term Efficacy ◽  
Kaplan Meier ◽  
Sf 36

Abstract Background: The incidence of fractures around the femoral prosthesis among patients undergoing hip arthroplasty is increasing and has become the third leading cause of hip revision. While numerous methods for the surgical treatment of periprosthetic femoral fractures (PFFs) have been proposed, only few reports have examined the long-term efficacy of surgical treatment. This study aims to examine the mid-and long-term efficacy of surgical treatment among patients with Vancouver B2 and B3 PFFs.Methods: This retrospective study evaluated the surgical outcomes of patients with Vancouver B2 and B3 PFFs between 2007 and 2011. The minimum follow-up time was eight years. Fracture healing, prosthesis stability, complications, patient quality of life SF-36 score, and survival rate were evaluated during the follow-up assessments.Results: A total of 83 patients were included and had an average follow-up period of 120.3 months. Among these patients, 69 were classified as Vancouver B2 and were treated with a distal fixation stem, whereas 14 cases were classified as Vancouver B3 and were treated with modular femoral prosthesis by using a proximal femoral allograft technique. A total of 15 patients underwent secondary revision surgery, and prosthesis dislocation was identified as the main cause of secondary revision. 80 (96.4%) cases of fractures were clinically healed. The mortality rate in the first year after surgery was 8.4% (7/83). The overall 5-year Kaplan–Meier survival rate for these patients was 75.9%. Meanwhile, the 5-year Kaplan–Meier survival rate for the implants was 86.9%. The final follow-up SF-36 score of the patients was 48.3 ± 9.8.Conclusions: Patients with Vancouver B2 and B3 PFFs show high mortality in the first year after their surgery, and the Kaplan–Meier analysis results showed that such mortality tends to plateau after 5 years. Prosthesis dislocation was identified as the primary cause of secondary revision.

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