Evaluation of Intensive Adjuvant Chemotherapy in Gastric Cancer Using Life Expectancy Compared with Log-Rank Test as a Measure of Survival Benefit

2006 ◽  
Vol 14 (2) ◽  
pp. 348-354 ◽  
Author(s):  
Toshikuni Nishikawa ◽  
Shunzo Maetani
BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yanrui Liang ◽  
Liying Zhao ◽  
Hao Chen ◽  
Tian Lin ◽  
Tao Chen ◽  
...  

Abstract Background The benefits of adjuvant chemotherapy for elderly patients with gastric cancer (GC) remain unknown because elderly patients are underrepresented in most clinical trials. This study aimed to evaluate the effectiveness and complications of adjuvant chemotherapy in patients > 65 years of age after laparoscopic D2 gastrectomy. Methods This was a single-center retrospective cohort study of elderly patients (> 65 years) with stage II/III GC who underwent curative laparoscopic D2 gastrectomy with R0 resection between 2004 and 2018. The adjuvant chemotherapy regimens included monotherapy (oral capecitabine) and doublet chemotherapy (oral capecitabine plus intravenous oxaliplatin [XELOX] or intravenous oxaliplatin, leucovorin, and 5-fluorouracil [FOLFOX]). The data were retrieved from a prospectively registered database maintained at the Department of General Surgery in Nanfang Hospital, China. The patients were divided as surgery alone and surgery plus adjuvant chemotherapy (chemo group). The overall survival (OS), disease-free survival (DFS), chemotherapy duration, and toxicity were examined. Results There were 270 patients included: 169 and 101 in the surgery and chemo groups, respectively. There were 10 (10/101) and six (6/101) patients with grade 3+ non-hematological and hematological adverse events. The 1−/3−/5-year OS rates of the surgery group were 72.9%/51.8%/48.3%, compared with 90.1%/66.4%/48.6% for the chemo group (log-rank test: P = 0.018). For stage III patients, the 1−/3−/5-year OS rates of the surgery group were 83.7%/40.7%/28.7%, compared with 89.9%/61.2%/43.6% for the chemo group (log-rank test: P = 0.015). Adjuvant chemotherapy was significantly associated with higher OS (HR = 0.568, 95%CI: 0.357–0.903, P = 0.017) and DFS (HR = 0.511, 95%CI: 0.322–0.811, P = 0.004) in stage III patients. Conclusions This study suggested that adjuvant chemotherapy significantly improves OS and DFS compared with surgery alone in elderly patients with stage III GC after D2 laparoscopic gastrectomy, with a tolerable adverse event profile.


2020 ◽  
Vol 10 ◽  
Author(s):  
Zhiju Chen ◽  
Shaowei Li ◽  
Yehong Wang ◽  
Zhiming Fu ◽  
Ning Liu ◽  
...  

BackgroundIt is well known that neoadjuvant radiotherapy could reduce local recurrence followed by surgical resection. However, evidence about oncologic efficacy of radiotherapy and survival benefit of adjuvant chemotherapy after neoadjuvant radiotherapy is still lacking.MethodsThis retrospective propensity score-matched cohort study identified patients with pathologically confirmed rectal cancer and receiving surgery with curative intent from the Surveillance, Epidemiology, and End Results database from 2004 through 2014. Overall survival was compared using the stratified log-rank test. Multivariate Cox regression analysis was used for identifying risk factor and developing prediction nomogram.ResultsA total of 22,008 (11,004 for each group) propensity-matched patients were identified. In the context of receiving adjuvant chemotherapy after surgical resection, there was no significant difference in terms of overall survival between surgery alone group and neoadjuvant radiotherapy and surgery group, whether for stage I (log-rank test p = 0.467), stage II (log-rank test p = 0.310), or stage III (p = 0.994). In case of receiving a prior combination therapy of neoadjuvant radiotherapy and surgery, the following adjuvant chemotherapy could significantly improve overall survival for patients with stage I (log-rank test p <0.001), stage II (log-rank test p = 0.038), and stage III (log-rank test p = 0.014). Nomogram integrating clinicopathologic factors was developed to predict survival benefit associated with neoadjuvant radiotherapy. Calibration and ROC curves validated promising performance for the nomogram.ConclusionPatients with rectal cancer underwent neoadjuvant radiotherapy yield acceptable outcomes and are more likely to benefit from adjuvant chemotherapy in terms of overall survival. These data would be evidential for advocating consistency in guideline adherence to the use of adjuvant chemotherapy after neoadjuvant radiotherapy.


2020 ◽  
Author(s):  
Yanrui Liang ◽  
Liying Zhao ◽  
Hao Chen ◽  
Tian Lin ◽  
Tao Chen ◽  
...  

Abstract Background: The benefits of adjuvant chemotherapy for elderly patients (age >65) with gastric cancer (GC) remain unknown because elderly patients are underrepresented in most clinical trials. To evaluate the effectiveness and complications of adjuvant chemotherapy in elderly patients (>65 years of age) after laparoscopic D2 gastrectomy.Methods: This was a retrospective cohort study of elderly patients (>65 years) with stage II/III GC who underwent curative laparoscopic D2 gastrectomy between 2004 and 2018. The patients were divided as surgery alone and surgery plus adjuvant chemotherapy (chemo group). The overall survival (OS), disease-free survival (DFS), circulating tumor cells (CTCs), chemotherapy duration, and toxicity were examined. Results: There were 270 patients included: 169 and 101 in the surgery and chemo groups, respectively. There were ten (10/101) and six (6/101) patients with grade 3+ non-hematological and hematological adverse events. The 1-/3-/5-year OS rates of the surgery group were 72.9%/51.8%/48.3%, compared with 90.1%/66.4%/48.6% for the chemo group (log-rank test: P=0.018). For stage III patients, the 1-/3-/5-year OS rates of the surgery group were 83.7%/40.7%/28.7%, compared with 89.9%/61.2%/43.6% for the chemo group (log-rank test: P=0.015). Adjuvant chemotherapy was significantly associated with higher OS (HR=0.568, 95%CI: 0.357-0.903, P=0.017) and DFS (HR=0.511, 95%CI: 0.322-0.811, P=0.004) in stage III patients. CTC >0 had no significant impact on the benefits of adjuvant chemotherapy on OS and DFS.Conclusions: This study suggested that adjuvant chemotherapy significantly improves OS and DFS for elderly patients with stage III GC after D2 laparoscopic gastrectomy, with a tolerable adverse event profile.


2003 ◽  
Vol 21 (12) ◽  
pp. 2282-2287 ◽  
Author(s):  
Atsushi Nashimoto ◽  
Toshifusa Nakajima ◽  
Hiroshi Furukawa ◽  
Masatsugu Kitamura ◽  
Taira Kinoshita ◽  
...  

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.


2018 ◽  
Vol 160 (4) ◽  
pp. 658-663 ◽  
Author(s):  
Phoebe Kuo ◽  
Sina J. Torabi ◽  
Dennis Kraus ◽  
Benjamin L. Judson

Objective In advanced maxillary sinus cancers treated with surgery and radiotherapy, poor local control rates and the potential for organ preservation have prompted interest in the use of systemic therapy. Our objective was to present outcomes for induction compared to adjuvant chemotherapy in the maxillary sinus. Study Design Secondary database analysis. Setting National Cancer Database (NCDB). Subjects and Methods In total, 218 cases of squamous cell maxillary sinus cancer treated with surgery, radiation, and chemotherapy between 2004 and 2012 were identified from the NCDB and stratified into induction chemotherapy and adjuvant chemotherapy cohorts. Univariate Kaplan-Meier analyses were compared by log-rank test, and multivariate Cox regression was performed to evaluate overall survival when adjusting for other prognostic factors. Propensity score matching was also used for further comparison. Results Twenty-three patients received induction chemotherapy (10.6%) and 195 adjuvant chemotherapy (89.4%). The log-rank test comparing induction to adjuvant chemotherapy was not significant ( P = .076). In multivariate Cox regression when adjusting for age, sex, race, comorbidity, grade, insurance, and T/N stage, there was a significant mortality hazard ratio of 2.305 for adjuvant relative to induction chemotherapy (confidence interval, 1.076-4.937; P = .032). Conclusion Induction chemotherapy was associated with improved overall survival in comparison to adjuvant chemotherapy in a relatively small cohort of patients (in whom treatment choice cannot be characterized), suggesting that this question warrants further investigation in a controlled clinical trial before any recommendations are made.


2019 ◽  
Vol 111 (11) ◽  
pp. 1186-1191 ◽  
Author(s):  
Julien Péron ◽  
Alexandre Lambert ◽  
Stephane Munier ◽  
Brice Ozenne ◽  
Joris Giai ◽  
...  

Abstract Background The treatment effect in survival analysis is commonly quantified as the hazard ratio, and tested statistically using the standard log-rank test. Modern anticancer immunotherapies are successful in a proportion of patients who remain alive even after a long-term follow-up. This new phenomenon induces a nonproportionality of the underlying hazards of death. Methods The properties of the net survival benefit were illustrated using the dataset from a trial evaluating ipilimumab in metastatic melanoma. The net survival benefit was then investigated through simulated datasets under typical scenarios of proportional hazards, delayed treatment effect, and cure rate. The net survival benefit test was computed according to the value of the minimal survival difference considered clinically relevant. As comparators, the standard and the weighted log-rank tests were also performed. Results In the illustrative dataset, the net survival benefit favored ipilimumab [Δ(0) = 15.8%, 95% confidence interval = 4.6% to 27.3%, P = .006]. This favorable effect was maintained when the analysis was focused on long-term survival differences (eg, >12 months, Δ(12) = 12.5% (95% confidence interval = 4.4% to 20.6%, P = .002). Under the scenarios of a delayed treatment effect and cure rate, the power of the net survival benefit test compared favorably to the standard log-rank test power and was comparable to the power of the weighted log-rank test for large values of the threshold of clinical relevance. Conclusion The net long-term survival benefit is a measure of treatment effect that is meaningful whether or not hazards are proportional. The associated statistical test is more powerful than the standard log-rank test when a delayed treatment effect is anticipated.


2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 13564-13564 ◽  
Author(s):  
S. Lonardi ◽  
M. Stefani ◽  
A. Jirillo ◽  
C. Ghiotto ◽  
L. M. Pasetto ◽  
...  

13564 Background: Retrospective analyses on elderly people enrolled in clinical trials of adjuvant chemotherapy for colon cancer indicated the maintenance of the efficacy in that subset of patients (pts). However, data on the benefit of the routinely used adjuvant treatment in an unselected population of pts aged more than 65 years are few. Methods: All the charts of pts radically operated for colon cancer from 1996–2001 at Medical Oncology, Padua Hospital, were retrospectively analysed. 147 out of 330 pts consecutively treated with fluorouracil (FU)-based chemotherapy was aged 65 years or more at the time of diagnosis. Kaplan-Meyer progression-free-survival (PFS) and overall survival (OS) of stage II and III pts were calculated. Results: Pts characteristics were: males/females: 87/60, median age 71 (range 65–87), ECOG PS 0/1: 124/23, right/left colon primary tumor: 62/85, TNM stage: 24/63/60. 86 out of 147 pts were treated with the following regimen of adjuvant chemotherapy: FU 370 mg/mq + leucovorin (LV) 20 mg/mq day 1–5 q 28 for 6 cycles (Machover regimen, n=69), or FU 500 mg/mq + LV 250 mg/mq weekly × 6 q 56 for 4 cycles (Roswell Park regimen, n=17). Treated pts were staged as follows: TNM stage I/II/III: 1/38/47. No toxic death were observed and only nine of 86 pts (10.4%) stopped the treatment due to acute grade III gastrointestinal toxicity. At a median follow-up of 73.2 months, 19 out of 86 pts (22%) developed cancer recurrence (3-y PFS: 82.2%, 5-y PFS: 80.3%). Seventeen pts (19.7%) died, 13 (15.1%) due to tumor progression, 3 (3.4%) due to acute heart failure, and 1 (1.1%) due to chronic pulmonary disease (3-y OS: 88.8%, 5-y OS: 82.4%). No statistically significant difference in survival was observed comparing pts aged 65–70 (n=41) with pts more than 70 years old (n=45): 5-y OS 84.1% vs 77.8%, respectively (p=2.23, log rank test). A separate survival analysis on stage II pts was performed (n=63). 5 of 38 (13.1) treated pts dead, compared to 9 of 25 (36%) non treated pts; 5-y survival in the two groups were 86.6% and 60.8%, respectively (p= 0.03, log-rank test). Conclusions: The efficacy of adjuvant chemotherapy appears maintained in an unselected population of elderly pts. Surprisingly, our retrospective analysis suggest that even stage II pts may benefit of a fluorouracil-based well tolerated chemotherapy. No significant financial relationships to disclose.


2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 105-105
Author(s):  
Yukio Maezawa ◽  
Tsutomu Sato ◽  
Toru Aoyama ◽  
Kazuki Kano ◽  
Kenki Segami ◽  
...  

105 Background: ACTS-GC trial demonstrated that S-1 is effective as adjuvant chemotherapy for Japanese patients who have undergone curative D2 gastrectomy for gastric cancer and were diagnosed with pathological stage II disease. However, stages T1N2M0 and T1N3M0, which are classified as part of Stage II, were excluded from the ACTS-GC trial. The aim of the present study was to identify the unfavorable subset of patients with T1N2M0 and T1N3M0 gastric cancer for whom surgery alone is the standard treatment. Methods: The present study examined 59 patients who were diagnosed with T1N2M0 or T1N3M0 gastric cancer at Kanagawa Cancer Center and Yokohama City University Hospital between January 2000 and June 2010. Univariate and multivariate analyses were performed to identify risk factors for overall survival using a Cox proportional hazards model. Results: When overall survival was compared by the log-rank test, a significant difference was observed with regard to macroscopic tumor diameter. A macroscopic tumor diameter greater than 30mm was regarded as a critical point of classification considering the survival. Mulitivariate Cox’s proportional hazard analyses demonstrated that macroscopic tumor diameter was the only significant independent prognosticator. The five-year survival was 60.0% in patients with a macroscopic tumor diameter < 30mm, and 84.6% in those with a macroscopic tumor diameter > 30mm (P = 0.027). Conclusions: Among T1N2M0 and T1N3M0 gastric cancer patients for whom surgery alone is the standard treatment, having a small T1N2-3 tumor of less than 30 mm in diameter was the sole risk factor for gastric cancer survival. These tumors might be another target for adjuvant chemotherapy.


2020 ◽  
Vol 18 (12) ◽  
pp. 1670-1677
Author(s):  
Amy A. Kirkham ◽  
Karen A. Gelmon ◽  
Cheri L. Van Patten ◽  
Kelcey A. Bland ◽  
Holly Wollmann ◽  
...  

Background: Available preliminary evidence is conflicting on whether exercise can positively influence antineoplastic treatment tolerance and in turn improve survival. Patients and Methods: This study compared chemotherapy treatment tolerance and survival among women receiving adjuvant chemotherapy for early-stage breast cancer who participated in a single-arm trial of supervised aerobic and resistance exercise programming versus a historical cohort that did not receive structured exercise programming. Results: The exercise group (EX; n=73) and control group (CTR; n=85) participants were matched on age and treatment and balanced on medical history, cancer diagnosis, and body mass index. Attendance in the EX group was 64% ± 27% of 3 offered sessions per week. For all chemotherapy agents combined, the relative risk (RR) of a chemotherapy dose reduction (RR, 0.78; 95% CI, 0.54–1.11) or delay (RR, 1.05; 95% CI, 0.62–1.80) did not differ between groups. However, the EX group had reduced relative and absolute risks of a dose reduction in doxorubicin by 60% and 18%, respectively. For all agents combined, there were no differences between groups in risk of anemia, neutropenia, or weight gain. In the EX group, dose reductions due to neutropenia (P=.027), other infections (P=.049), and fatigue (P=.037) were less common, whereas mucositis was more common (P=.023), compared with the CTR group. The EX group had reduced relative and absolute risks of weight gain on the docetaxel + cyclophosphamide regimen by 38% and 30%, respectively. After a median follow-up of 70 months (range, 54–84 months), there was no difference between the EX and CTR groups in disease-free survival events (n=8 [11%] vs n=9 [11%], respectively; log-rank test, P=.78) or overall survival events (n=5 [7%] vs n=6 [7%], respectively; log-rank test, P=.974). Conclusions: Overall, exercise programming during adjuvant chemotherapy does not appear to impact treatment tolerance or survival in women receiving common modern regimens of adjuvant chemotherapy for early-stage breast cancer. However, exercise may provide selective benefits, depending on the treatment regimen received.


2020 ◽  
Author(s):  
Chi Huang ◽  
Jiuying Ji ◽  
Tao Qian ◽  
Zongqi Fei ◽  
Binge Ma ◽  
...  

Abstract Background: Anaplastic thyroid carcinoma is a rare malignant tumor of the thyroid. In this study, we summarize the survival changes of Anaplastic thyroid carcinoma in recent years. Methods: Patients with Anaplastic thyroid carcinoma were selected from The Surveillance, Epidemiology, and End Results database (1973-2015). Survival rates were calculated and survival trends were compared among different stage, different years, under surgery and under radiotherapy or not.Results: A total of 1293 patients were enrolled in the study. The 5-year overall survival (OS) for Stage IVA, B and C were 26.6%, 11.7% and 2.5%, respectively. The 5-year cancer-specific survival (CSS) for the same respective stage were 43.5%, 22.3% and 4.9%. After year 1995, the CSS was further improvement (χ2=13.608, P=0.003 for log-rank test) and there was obvious improvement in survival for patients at stage IVB and stage IVC (stage IVB: χ2=12.987, P=0.005, stage IVC: χ2=21.992, P<0.001 for log-rank test). The surgery survival benefit was only observed in Stage IVB (OS: χ2=43.887, P<0.001, CSS: χ2=27.301, P<0.001 for log-rank test) and C (OS: χ2=16.399, P<0.001, CSS: χ2=12.521, P<0.001 for log-rank test). The radiotherapy OS benefit was observed in all different stage(stage IVA: χ2=7.346, P=0.007 for log-rank test, stage IVB: χ2=37.491, P<0.001 for log-rank test,stage IVC: χ2=23.208, P<0.001 for log-rank test) and the CSS benefit was observed in Stage IVB (χ2=18.717, P<0.001 for log-rank test) and C (χ2=12.615, P<0.001 for log-rank test). The median OS of patients with stage IV A receiving surgery, radiotherapy alone and the combination of the two is 4, 5 and 33 months (95% CI: 0.411-7.589, 0.000-10.500, 16.290-49.710, respectively). For Stage IVA patients, compared with the patients received surgery alone, the survival benefit was observed in patients who received surgery and radiotherapy combined (OS: χ2=6.454, P=0.011 for log-rank test). Conclusion: The 5-year cancer-specific survival for Anaplastic thyroid carcinoma was improved in recent years since 1990s. Patients with local metastasis or distant metastasis could benefit from surgery and radiotherapy. For Stage IVA patients, surgery or radiotherapy alone did not improve the cancer-specific survival. Combination of surgery and radiotherapy should get survival benefit.


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