Randomized controlled phase II study of alternate-day S-1 as adjuvant chemotherapy for gastric cancer.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 114-114
Author(s):  
Seiichi Nakamura ◽  
Shigeru Tatebe ◽  
Tetsu Shimizu ◽  
Nariyuki Yamane ◽  
Hideaki Nishidoi ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Survival Rate ◽  
Adjuvant Chemotherapy ◽  
Dose Intensity ◽  
Treatment Completion ◽  
Completion Rate ◽  
Relapse Free Survival ◽  
Free Survival ◽  
Group A ◽  
Group B

114 Background: Based on the results of ACTS-GC, oral administration of S-1 for 1 year is considered standard postoperative adjuvant chemotherapy for gastric cancer in Japan. However, the 1-year treatment completion rate was only 65.8%, and completion of the treatment is a problem to be solved. On the other hand, we experienced in clinical practice that the alternate-day administration of S-1 reduced adverse effects and was tolerable for advanced gastric cancer patients unwilling to continue the standard daily administration. We therefore conducted a multi-center cooperative prospective study to compare daily with alternate-day administration of S-1 as postoperative adjuvant therapy for gastric cancer. Methods: Patients with Stage II or III gastric cancer who underwent curative surgery were randomly assigned to receive standard daily administration (group A: S-1 80-120 mg/day according to BSA, days 1 to 28, every 6weeks, for 1 year) or alternate-day administration of S-1 (group B: S-1 80-120 mg/day according to BSA, every other day, for 15 months). The primary endpoints were treatment completion rate and relative dose intensity. Secondary endpoints were safety, overall survival, and relapse-free survival. Results: A total of 73 patients were enrolled. As of August 30, 2011 analysis of the compliance data of 62 cases had been completed. The results showed a treatment completion rate of 74.2% in group A and 93.5% in group B and relative dose intensity of 72.1% in group A and 85.6% in group B, and compliance tended to be better in group B. Assessment of survival time showed a median follow-up time of 545 days, a 1-year survival rate of 93.8% in group A and 96.9% in group B and 1-year relapse-free survival rate of 79.5% in group A and 90.7% in group B. Digestive system adverse events were less frequent in group B than in group A. Conclusions: We will report the data from the final analysis at this meeting. The current data show improved compliance and mitigation of adverse effects with alternate-day administration of S-1, and it appears to be a more sustainable option for adjuvant chemotherapy for Stage II and III gastric cancer.

Five-Year Outcomes of a Randomized Phase III Trial Comparing Adjuvant Chemotherapy With S-1 Versus Surgery Alone in Stage II or III Gastric Cancer

2011 ◽  
Vol 29 (33) ◽  
pp. 4387-4393 ◽  
Author(s):  
Mitsuru Sasako ◽  
Shinichi Sakuramoto ◽  
Hitoshi Katai ◽  
Taira Kinoshita ◽  
Hiroshi Furukawa ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Overall Survival ◽  
Survival Rate ◽  
Adjuvant Chemotherapy ◽  
Stage Ii ◽  
Disease Stage ◽  
Relapse Free Survival ◽  
Free Survival ◽  
End Point

Purpose The first planned interim analysis (median follow-up, 3 years) of the Adjuvant Chemotherapy Trial of S-1 for Gastric Cancer confirmed that the oral fluoropyrimidine derivative S-1 significantly improved overall survival, the primary end point. The results were therefore opened at the recommendation of an independent data and safety monitoring committee. We report 5-year follow-up data on patients enrolled onto the ACTS-GC study. Patients and Methods Patients with histologically confirmed stage II or III gastric cancer who underwent gastrectomy with D2 lymphadenectomy were randomly assigned to receive S-1 after surgery or surgery only. S-1 (80 to 120 mg per day) was given for 4 weeks, followed by 2 weeks of rest. This 6-week cycle was repeated for 1 year. The primary end point was overall survival, and the secondary end points were relapse-free survival and safety. Results The overall survival rate at 5 years was 71.7% in the S-1 group and 61.1% in the surgery-only group (hazard ratio [HR], 0.669; 95% CI, 0.540 to 0.828). The relapse-free survival rate at 5 years was 65.4% in the S-1 group and 53.1% in the surgery-only group (HR, 0.653; 95% CI, 0.537 to 0.793). Subgroup analyses according to principal demographic factors such as sex, age, disease stage, and histologic type showed no interaction between treatment and any characteristic. Conclusion On the basis of 5-year follow-up data, postoperative adjuvant therapy with S-1 was confirmed to improve overall survival and relapse-free survival in patients with stage II or III gastric cancer who had undergone D2 gastrectomy.

Randomized Trial of Adjuvant Chemotherapy With Mitomycin, Fluorouracil, and Cytosine Arabinoside Followed by Oral Fluorouracil in Serosa-Negative Gastric Cancer: Japan Clinical Oncology Group 9206–1

2003 ◽  
Vol 21 (12) ◽  
pp. 2282-2287 ◽  
Author(s):  
Atsushi Nashimoto ◽  
Toshifusa Nakajima ◽  
Hiroshi Furukawa ◽  
Masatsugu Kitamura ◽  
Taira Kinoshita ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Overall Survival ◽  
Adjuvant Chemotherapy ◽  
Survival Benefit ◽  
Curative Resection ◽  
Cancer Recurrence ◽  
Phase Iii ◽  
Relapse Free Survival ◽  
Free Survival ◽  
Significant Difference

Purpose: To evaluate the survival benefit of adjuvant chemotherapy after curative resection in serosa-negative gastric cancer patients (excluding patients who were T1N0), we conducted a multicenter phase III clinical trial in which 13 cancer centers in Japan participated. Patients and Methods: From January 1993 to December 1994, 252 patients were enrolled into the study and allocated randomly to adjuvant chemotherapy or surgery alone. The chemotherapy comprised intravenous mitomycin 1.33 mg/m2, fluorouracil (FU) 166.7 mg/m2, and cytarabine 13.3 mg/m2 twice weekly for the first 3 weeks after surgery, and oral FU 134 mg/m2 daily for the next 18 months for a total dose of 67 g/m2. The primary end point was relapse-free survival. Overall survival and the site of recurrence were secondary end points. Results: Ninety-eight percent of patients underwent gastrectomy with D2 or greater lymph node dissection. There were no treatment-related deaths and few serious adverse events. There was no significant difference in relapse-free and overall survival between the arms (5-year relapse-free survival 88.8% chemotherapy v 83.7% surgery alone; P = .14 and 5-year survival 91.2% chemotherapy v 86.1% surgery alone; P = .13, respectively). Nine patients (7.1%) in the chemotherapy arm and 17 patients (13.8%) in the surgery-alone arm had cancer recurrence. Conclusion: There was no statistically significant relapse-free or overall survival benefit with this adjuvant chemotherapy for patients with macroscopically serosa-negative gastric cancer after curative resection, and there was no statistical difference between the two arms relating to the types of cancer recurrence. We do not recommend adjuvant chemotherapy with this regimen for this population in clinical practice.

scholarly journals Adjuvant chemotherapy is an additional option for locally advanced gastric cancer after radical gastrectomy with D2 lymphadenectomy: a retrospective control study

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Lei Chen ◽  
Chenghai Zhang ◽  
Zhendan Yao ◽  
Ming Cui ◽  
Jiadi Xing ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Adjuvant Chemotherapy ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Stage Ii ◽  
Radical Gastrectomy ◽  
D2 Lymphadenectomy ◽  
D2 Gastrectomy ◽  
Group A ◽  
Group B

Abstract Background This study compared the long-term efficacy of different durations of adjuvant chemotherapy for patients with gastric cancer after radical gastrectomy with D2 lymphadenectomy. Methods We retrospectively identified 428 patients with stage II–III gastric cancer who underwent D2 gastrectomy between 2009 and 2016. Patients were divided into four groups according to the duration of adjuvant chemotherapy, including 0 week (no adjuvant, group A), 20 to 24 weeks (completed 7–8 cycles every 3 weeks or 10–12 cycles every 2 weeks, group B), and 12 to18 weeks (completed 4–6 cycles every 3 weeks or 6–9 cycles every 2 weeks, group C), and less than 12 weeks (received up to 3 cycles every 3 weeks or 5 cycles every 2 weeks, group D). The chemotherapy regimens included XELOX, SOX, and FOLFOX. 5-year overall survival (OS) and disease-free survival (DFS) were analyzed. Results The 5-year OS rates for groups A, B, C, and D were 52.3, 73.7, 72.0, and 53.3%, respectively, and the 5-year DFS rates were 50.0, 68.0, 65.4, and 50.0%, respectively. OS and DFS were higher in group B than in groups A and D. Similarly, patients in group C were more likely to have higher OS and DFS than those in groups A and D. Meanwhile, there were no significant differences in OS and DFS between groups B and C. The multivariate analysis confirmed with high statistical significance the efficacy of complete courses of adjuvant chemotherapy, and, among them, the similar impact of 4–6/6–9 and 7–8/10–12 cycles, resulting in similar HRs vs Group A (0.52 and 0.42, respectively). Conclusions To reduce toxicity and maintain efficacy, XELOX or SOX chemotherapy regimens administered for 4–6 cycles every 3 weeks or FOLFOX regimen for 6–9 cycles every 2 weeks might be a favorable option for patients with stage II–III gastric cancer after D2 gastrectomy. Prospective multicenter clinical trials with adequate sample sizes are necessary to verify these findings.

A prospective, randomized, controlled, multicenter study of apatinib combined with S-1 plus docetaxel as adjuvant therapy for locally advanced gastric cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16019-e16019
Author(s):  
Zhili Shan ◽  
Feng Guo ◽  
Hong Chen ◽  
Dapeng Li ◽  
Zhongqi Mao ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Free Survival ◽  
Randomized Controlled ◽  
Locally Advanced Gastric Cancer ◽  
Group A ◽  
Group B ◽  
Disease Free

e16019 Background: Postoperative adjuvant chemotherapy is commonly given after the curative resection of gastric cancer (GC) in both Eastern and Western countries. Several studies have investigated the feasibility and safety of S-1 plus docetaxel or S-1 plus cisplatin. However, the best choice of adjuvant treatment for patients with gastric cancer is still debated. Apatinib, an oral small molecular of VEGFR-2 TKI, has been confirmed to improve OS and PFS with acceptable safety profile in patients with advanced gastric cancer refractory to two or more lines of prior chemotherapy. In this study, we aimed to evaluate the efficacy and safety of apatinib combined with S-1/docetaxel for locally advanced gastric cancer (T3-4aN+M0). Methods: This is a prospective, randomized, controlled, multicenter clinical study. Patients with locally advanced gastric cancer, pathological stage T3-4aN+M0 who underwent D2 lymphadenectomy without prior anti-cancer therapy were included. All these patients were assigned to group A or B. Patients in group A received 6 cycles (21 days a cycle) of adjuvant therapy using S-1 (80-120mg/d, d1-14), and docetaxel (40mg/m2, d1). Group B received the same regimen with the addition of apatinib (250mg, qd.). The primary endpoint was disease-free survival (DFS). The final analysis cutoff date was 30 November, 2020. Results: A total of 45 patients were enrolled from January 2019 to November, 2010 and assigned to group A (21) or group B (24). The DFS was not reached in both of the groups. The 1-year disease-free survival rate was 60% in group A and 90% in the group B, while the difference was not significant. The main AEs in group A were anemia (55%), nausea (50%) and neutropenia (40%); The most common AEs in group B were anemia (45%) neutropenia (40%) and diarrhea (25%). There were no treatment-related deaths. The longest administered time of apatinib with no progression was 457 days. And the median time to receive apatinib was 329 days. Conclusions: Combination of apatinib with S-1/docexal chemotherapy shows clinical benefits in locally advanced gastric cancer (T3-4aN+M0), with tolerable toxicity. The study is still ongoing to reach our final endpoint, DFS. Clinical trial information: ChiCTR2000038900.

Randomized Clinical Trial of Adjuvant Mitomycin Plus Tegafur in Patients With Resected Stage III Gastric Cancer

1999 ◽  
Vol 17 (12) ◽  
pp. 3810-3815 ◽  
Author(s):  
Lluís Cirera ◽  
Anna Balil ◽  
Eduard Batiste-Alentorn ◽  
Ignasi Tusquets ◽  
Teresa Cardona ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Clinical Trial ◽  
Overall Survival ◽  
Survival Rate ◽  
Adjuvant Chemotherapy ◽  
Disease Free Survival ◽  
Stage Iii ◽  
Free Survival ◽  
Resected Stage ◽  
Disease Free

PURPOSE: The efficacy of adjuvant chemotherapy in gastric cancer is controversial. We conducted a phase III, randomized, multicentric clinical trial with the goal of assessing the efficacy of the combination of mitomycin plus tegafur in prolonging the disease-free survival and overall survival of patients with resected stage III gastric cancer. PATIENTS AND METHODS: Patients with resected stage III gastric adenocarcinoma were randomly assigned, using sealed envelopes, to receive either chemotherapy or no further treatment. Chemotherapy was started within 28 days after surgery according to the following schedule: mitomycin 20 mg/m2 intravenously (bolus) at day 1 of chemotherapy; 30 days later, oral tegafur at 400 mg bid daily for 3 months. Disease-free survival and overall survival were estimated using the Kaplan-Meier analysis and the Cox proportional hazards model. RESULTS: Between January 1988 and September 1994, 148 patients from 10 hospitals in Catalonia, Spain, were included in the study. The median follow-up period was 37 months. The tolerability of the treatment was excellent. The overall survival and disease-free survival were higher in the group of patients treated with chemotherapy (P = .04 for survival and P = .01 for disease-free survival in the log-rank test). The overall 5-year survival rate and the 5-year disease-free survival rate were, respectively, 56% and 51% in the treatment group and 36% and 31% in the control group. CONCLUSION: Our positive results are consistent with the results of recent studies; which conclude that there is a potential benefit from adjuvant chemotherapy in resected gastric cancer.

Effect of post-operative intra-abdominal infectious complications on overall and relapse-free survival following curative gastrectomy in patients with gastric cancer.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 86-86
Author(s):  
Masanori Tokunaga ◽  
Yutaka Tanizawa ◽  
Etsuro Bando ◽  
Taiichi Kawamura ◽  
Masanori Terashima
Keyword(s):  
Gastric Cancer ◽  
Survival Rate ◽  
Infectious Complications ◽  
Pathological Stage ◽  
Relapse Free Survival ◽  
Curative Gastrectomy ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Free Survival

86 Background: The number of reports investigating the impact of postoperative complications on long-term outcome following curative gastrectomy is limited and still remains unclear. The aim of this study is to clarify the effect of postoperative intra-abdominal infectious complications on overall survival (OS) and relapse-free survival (RFS) following curative gastrectomy. Methods: Three hundred and sixty-seven patients pts who underwent curative gastrectomy for gastric cancer between June 2003 and December 2004 at Shizuoka Cancer Center were included. Clinicopathological features and effects of postoperative intra-abdominal infectious complications on OS and RFS were investigated. In this study, postoperative intra-abdominal infectious complications were defined as Clavien-Dindo grade II or more severe pancreas fistula, anastomotic leak, or intra-abdominal abscess. Results: Median age was 63 years, male-female ratio was 2:1. Pathological stage was Stage I; 225 patients, stage II; 72 patients, stage III; 64 patients, and stage IV; 6 patients. Median observation periods of survivors were 71 months. Of 367 patients, 32 patients (8.7%) had intra-abdominal infectious complications. Overall 5-year survival rate was significantly better in patients without complications than in those with complications (86.1 vs 67.9%, P<0.001). The same trend was observed even after stratification by pathological stage (Stage II; 76.9 vs 66.7%, P=0.254, Stage III; 62.1 vs 40.9%, P=0.218) although each difference was not statistically significant. Relapse free 5-year survival rate was significantly better in patient without complications (85.0 vs 64.9%, P=0.002), and the same trend was also observed after stratification by pathological stage. Conclusions: Postoperative intra-abdominal infectious complications adversely affect overall and relapse free survival of patients following curative gastrectomy. Reduced incidence of infectious complications may be beneficial to improve long-term outcome of patients with gastric cancer.

A prospective multicenter trial of S-1 with lafutidine vs S-1 as adjuvant chemotherapy for gastric cancer in Japan: AEOLUS.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 91-91
Author(s):  
Nozomu Machida ◽  
Masanori Terashima ◽  
Keisei Taku ◽  
Takashi Daimon ◽  
Masashi Kimura ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Adjuvant Chemotherapy ◽  
Dose Reduction ◽  
Treatment Completion ◽  
Multicenter Trial ◽  
Completion Rate ◽  
Placebo Control ◽  
Double Blind ◽  
Cytologic Examination ◽  
Significance Level

91 Background: From the result of ACTS-GC study, adjuvant chemotherapy with S-1 for one year is standard therapy of gastric cancer in Japan. In this study, completion rate of pre-planned S-1 treatment was 65.8% and there is still room for improvement on this rate. Lafutidine is a H2 blocker and enhances submucosal blood flow via capsaicin-sensitive afferent neurons. Alleviating effect of lafutidine on toxicity of 5FU leading to discontinuation of adjuvant treatment could be expected. Methods: Patients with histologically confirmed stage II (excluding T1 cases), IIIA, or IIIB (Japanese Classification of Gastric Carcinoma 13th) who underwent gastrectomy with D2 lymphadenectomy were randomly assigned to receive S-1 with lafutidine(L) or S-1 (S). All patients were given S-1 (40mg/m2) for 4 weeks with 2 weeks rest, repeated for 1 year after surgery. Patients of L group received lafutidine (20mg/day) every day for 1 year with S-1. The primary end point was treatment completion rate (TCR) of S-1. Definition of treatment completion was S-1 continuation for 1 year with over 70% planned dose. The secondary end points were toxicity (CTCAE v3.0) and relative total administration dose (RD) of S-1. Results: We randomly assigned 101 patients to the L group and 101 patients to the S group between February 2010 and December 2012 from 17 centers in Japan. After randomization, two patients were found to be ineligible in L group (the absence of cytologic examination of the peritoneal fluid, stageIB) and 1 in S group (allocation violation). TCR was 68.3% in the L group and 60.4% in the S group (p = 0.072, Cochran-Mantel-Haenzel test at a pre-specified one-sided significance level of 0.1). Adverse events of grade 3/4 excluding ineligible example was 30.0% in the L group, and 36.0% in the S group. Patients who require a dose reduction and/or delay of S-1 was 41.6% in the L group, and 51.5% in the S group. RD was 83.9% (range: 1.6-103.7) in the L group, and 84.0% (range: 1.7-103.8) in the S group. No any toxicity of lafutidine was observed. Conclusions: Lafutidine may increase a completion rate of adjuvant chemotherapy using S-1 within a 30% dose reduction for gastric cancer. This result need to be confirmed in double-blind placebo control study. Clinical trial information: UMIN000002703.

scholarly journals Prognostic effect of postoperative duration until adjuvant chemotherapy and cumulative S-1 dose in gastric cancer

2020 ◽  
Author(s):  
Yusuke Takashima ◽  
Shuhei Komatsu ◽  
Keiji Nishibeppu ◽  
Tomohiro Arita ◽  
Toshiyuki Kosuga ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Adjuvant Chemotherapy ◽  
C Reactive Protein ◽  
Relapse Free Survival ◽  
Curative Gastrectomy ◽  
Free Survival ◽  
Prognostic Effect ◽  
Reactive Protein ◽  
The Poor ◽  
Grade Ii

Abstract BackgroundAdjuvant chemotherapy (AC) following curative gastrectomy for stage II/III gastric cancer (GC) is recommended in Japan. However, for various reasons, patients cannot always start AC at the appropriate time. This study was designed to investigate the effect of the postoperative duration until adjuvant chemotherapy (PDAC) and cumulative S-1 dose on prognosis.MethodsBetween 2008 and 2014, 76 consecutive GC patients who underwent postoperative S-1 monotherapy were enrolled in this study.ResultsPostoperative complications of Clavien–Dindo grade II or higher and postoperative peak C-reactive protein of 8 mg/dl or higher were significantly associated with delayed AC. The cut-off value of PDAC selected to most effectively stratify prognosis was 7 weeks. For relapse-free survival (RFS), patients with PDAC ≥ 7 weeks had an insignificantly poorer prognosis than those with PDAC < 7 weeks (p = 0.017, 5-year RFS: PDAC ≥ 7 weeks vs. PDAC < 7 weeks, 48.5% vs. 77.0%). A multivariate analysis showed that PDAC ≥ 7 weeks [p = 0.007; hazard ratio (HR) 3.99 (95% CI: 1.46–11.5)] and cumulative S-1 dose > 12,000 mg [p = 0.033; HR 0.38 (95% CI: 0.14–0.93)] were independent prognostic factors. In patients with a cumulative S-1 dose ≥ 12,000 mg, there were no prognostic differences between patients with and without PDAC ≥ 7 weeks.Conclusions7 weeks after surgery could be an indicator starting AC. A cumulative S-1 dose of more than 12,000 mg might be a key dose for diminishing the poor prognostic effects of delaying AC.

Effects of perioperative enteral EPA-enriched immunonutrition on meaningful loss of lean body mass after total gastrectomy for gastric cancer: Post hoc analysis of a phase III study.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 85-85
Author(s):  
Takaki Yoshikawa ◽  
Naoki Hiki ◽  
Kentaro Sakamaki ◽  
Seiji Ito ◽  
Kazumasa Fujitani ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Adjuvant Chemotherapy ◽  
Enteral Nutrition ◽  
Total Gastrectomy ◽  
Phase Iii ◽  
Standard Diet ◽  
Group A ◽  
Phase Iii Study ◽  
Group B ◽  
Post Hoc

85 Background: Total gastrectomy for gastric cancer significantly reduces body weight, especially lean body mass (LBM), through surgical stress and decrease of the calorie intake. Eicosapentaenoic acid (EPA)-enriched enteral nutrition (EPA-EN) could modulate immune function and limits catabolism. In our phase III study to compare perioperative standard diet with or without EPA-EN, additional EPA-EN did not contribute to prevent weight loss or LBM. Recently, 5% or more LBM loss after surgery was reported to impair compliance of post-operative S-1 adjuvant chemotherapy. This post hoc study explored whether additional EPA-EN prevented meaningful loss of LBM for compliance of adjuvant chemotherapy after surgery. Methods: Key entry criteria of this phase III study was (1) histologically proven adenocarcinoma of the stomach, (2) clinical T1-T4a and M0, (3) R0 resection is possible by total gastrectomy, (4) sufficient oral intake, and (5) sufficient organ function. The patients were randomized to Group A: no supplementation with oral nutrients (standard diet) or Group B: standard diet with oral supplementation of ProSure including 600 kcal with 2.2 g EPA for 7 days before surgery and for 21 days after surgery. For both groups, patients underwent total gastrectomy with Roux-en Y reconstruction. Results: A total of 127 patients (Group A: 63, Group B: 64) were enrolled in the study. All background factors were well balanced between the both groups. Median relative performance of supplement in group B was 100% before surgery and 54% after surgery. 5% or more LBM loss at 1 month after surgery was observed in 44 patients (80.0%) in group A and in 37 patients (67.3%) in group B (p = 0.194), while that at 3 months after surgery was found in 51 patients (91.1%) in group A and in 43 patients (76.8%) in group B (p = 0.070). Conclusions: Perioperative standard diet with EPA-enriched enteral nutrition tended to prevent meaningful loss of LBM after total gastrectomy. Further analysis is required whether perioperative EPA enriched EN improve compliance of S-1 adjuvant chemotherapy after total gastrectomy. Clinical trial information: UMIN000006380.

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