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Association of Adjuvant Therapy with Improved Survival in Ampullary Cancer: A National Cohort Study.

ABSTRACT: BACKGROUND:There are limited data on the efficacy of adjuvant therapy in ampullary cancer. The aim of this study was to determine whether adjuvant therapy was associated with improved survival for patients with ampullary cancer. METHODS:From the National Cancer Database, we identified ampullary cancer patients who underwent resection between 2004 and 2013. We performed 1:1 propensity score matching, comparing patients who had postoperative observation to patients who received adjuvant chemotherapy (ACT) or adjuvant chemoradiotherapy (ACRT). RESULTS:We identified 4190 patients who fit our inclusion criteria; 63% had postoperative observation, 21% received ACT, and 16% underwent ACRT. In the matched cohorts, the use of ACT was associated with improved overall survival (HR = 0.82, 95% CI = 0.71 to 0.95). The median overall survival was 47.2 months for the ACT group and 35.5 months for the observation group. In a separate matched analysis, ACRT was also associated with improved survival (HR = 0.84, 95% CI = 0.72 to 0.98) as compared to observation. The median overall survival was 38.1 months for the ACRT group and 31.0 months for the observation group. The benefit was more pronounced in high-risk patients, such as ones with higher T and N categories. CONCLUSIONS:In this retrospective study, the use of adjuvant therapy in ampullary cancer was associated with significantly improved overall survival. The benefit of adjuvant therapy for this disease should be confirmed in a more rigorous fashion via randomized controlled trials.

SUBMITTER: Nassour I

PROVIDER: S-EPMC5890432 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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Association of Adjuvant Therapy with Improved Survival in Ampullary Cancer: A National Cohort Study.

Nassour Ibrahim I Hynan Linda S LS Christie Alana A Minter Rebecca M RM Yopp Adam C AC Choti Michael A MA Mansour John C JC Porembka Matthew R MR Wang Sam C SC

Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract 20171110 4

<h4>Background</h4>There are limited data on the efficacy of adjuvant therapy in ampullary cancer. The aim of this study was to determine whether adjuvant therapy was associated with improved survival for patients with ampullary cancer.<h4>Methods</h4>From the National Cancer Database, we identified ampullary cancer patients who underwent resection between 2004 and 2013. We performed 1:1 propensity score matching, comparing patients who had postoperative observation to patients who received adju ...[more]

PMID: 29127604

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Project description:ObjectiveThere are no randomized data to support the use of postoperative radiation for salivary gland malignancies. This study uses the National Cancer Database (NCDB) to describe the epidemiology of salivary gland cancer patients and to investigate whether treatment with adjuvant radiation improves overall survival.Methods and materialsA total of 8243 patients diagnosed with a major salivary gland cancer were identified from the NCDB. All patients received primary surgical resection of their malignancy. Patients were risk-stratified by adverse features, and overall survival rates were determined. Patients were considered high risk if they had extracapsular extension and/or positive margin after resection. Patients were considered intermediate risk if they did not meet the criteria for high risk but had pT3-T4 disease, pN+ disease, lymphovascular space invasion, adenoid cystic histology, or grade 2-3 disease. Patients who did not meet criteria for high or intermediate risk were considered low risk. Overall patient demographics, disease characteristics, treatment factors, and outcomes were summarized with descriptive statistics and analyzed with STATA.ResultsMedian follow-up in this cohort was 42.4 months, with the median age of 58 years. Patients in the high-risk group had greater survival (hazard ratio [HR], 0.76; P = .002; 95% confidence interval [CI], 0.64-0.91) if they received adjuvant radiation therapy. In contrast, patients in the intermediate- (HR, 1.01; P = .904; 95% CI, 0.85-1.20) and low-risk groups (HR, 0.85; P = .427; 95% CI, 0.57-1.26) did not experience a survival benefit with adjuvant radiation therapy.ConclusionsThis large analysis compared survival outcomes between observation and adjuvant radiation alone in risk-stratified patients after resection of major salivary glands using a national database. The use of adjuvant radiation for high-risk major salivary gland cancers appears to offer a survival benefit. Although an overall survival benefit was not seen in low- and intermediate-risk salivary gland cancers, this study could not address impact on local control because of the limitations of the NCDB.

Project description:BackgroundRecurrence following radical resection in patients with stage IB gastric cancer (GC) is not uncommon. However, whether postoperative adjuvant chemotherapy could reduce the risk of recurrence in stage IB GC remains contentious.MethodsWe collected data on 2110 consecutive patients with pathologic stage IB (T1N1M0 or T2N0M0) GC who were admitted to 8 hospitals in China from 2009 to 2018. The survival of patients who received adjuvant chemotherapy was compared with that of postoperative observation patients using propensity score matching (PSM). Two survival prediction models were constructed to estimate the predicted net survival gain attributable to adjuvant chemotherapy.FindingsOf the 2110 patients, 1344 received adjuvant chemotherapy and 766 received postoperative observation. Following the 1-to-1 matching, PSM yielded 637 matched pairs. Among matched pairs, adjuvant chemotherapy was not associated with improved survival compared with postoperative observation (OS: hazard ratio [HR], 0.72; 95% CI, 0.52-1.00; DFS: HR, 0.91; 95% CI, 0.64-1.29). Interestingly, in the subgroup analysis, reduced mortality after adjuvant chemotherapy was observed in the subgroups with elevated serum CA19-9 (HR, 0.22; 95% CI, 0.08-0.57; P = 0.001 for multiplicative interaction), positive lymphovascular invasion (HR, 0.32; 95% CI, 0.17-0.62; P < 0.001 for multiplicative interaction), or positive lymph nodes (HR, 0.17; 95% CI, 0.07-0.38; P < 0.001 for multiplicative interaction). The survival prediction models mainly based on variables associated with chemotherapy benefits in the subgroup analysis demonstrated good calibration and discrimination, with relatively high C-indexes. The C-indexes for OS were 0.74 for patients treated with adjuvant chemotherapy and 0.70 for patients treated with postoperative observation. Two nomograms were built from the models that can calculate individualized estimates of expected net survival gain attributable to adjuvant chemotherapy.InterpretationIn this cohort study, pathologic stage IB alone was not associated with survival benefits from adjuvant chemotherapy compared with postoperative observation in patients with early-stage GC. High-risk clinicopathologic features should be considered simultaneously when evaluating patients with stage IB GC for adjuvant chemotherapy.FundingNational Natural Science Foundation of China; the National Key R&D Program of China.

Project description:ImportanceAmpullary adenocarcinoma is a rare malignant neoplasm that arises within the duodenal ampullary complex. The role of adjuvant therapy (AT) in the treatment of ampullary adenocarcinoma has not been clearly defined.ObjectiveTo determine if long-term survival after curative-intent resection of ampullary adenocarcinoma may be improved by selection of patients for AT directed by histologic subtype.Design, setting, and participantsThis multinational, retrospective cohort study was conducted at 12 institutions from April 1, 2000, to July 31, 2017, among 357 patients with resected, nonmetastatic ampullary adenocarcinoma receiving surgery alone or AT. Cox proportional hazards regression was used to identify covariates associated with overall survival. The surgery alone and AT cohorts were matched 1:1 by propensity scores based on the likelihood of receiving AT or by survival hazard from Cox modeling. Overall survival was compared with Kaplan-Meier estimates.ExposuresAdjuvant chemotherapy (fluorouracil- or gemcitabine-based) with or without radiotherapy.Main outcomes and measuresOverall survival.ResultsA total of 357 patients (156 women and 201 men; median age, 65.8 years [interquartile range, 58-74 years]) underwent curative-intent resection of ampullary adenocarcinoma. Patients with intestinal subtype had a longer median overall survival compared with those with pancreatobiliary subtype (77 vs 54 months; P = .05). Histologic subtype was not associated with AT administration (intestinal, 52.9% [101 of 191]; and pancreatobiliary, 59.5% [78 of 131]; P = .24). Patients with pancreatobiliary histologic subtype most commonly received gemcitabine-based regimens (71.0% [22 of 31]) or combinations of gemcitabine and fluorouracil (12.9% [4 of 31]), whereas treatment of those with intestinal histologic subtype was more varied (fluorouracil, 50.0% [17 of 34]; gemcitabine, 44.1% [15 of 34]; P = .01). In the propensity score-matched cohort, AT was not associated with a survival benefit for either histologic subtype (intestinal: hazard ratio, 1.21; 95% CI, 0.67-2.16; P = .53; pancreatobiliary: hazard ratio, 1.35; 95% CI, 0.66-2.76; P = .41).Conclusions and relevanceAdjuvant therapy was more frequently used in patients with poor prognostic factors but was not associated with demonstrable improvements in survival, regardless of tumor histologic subtype. The value of a multimodality regimen remains poorly defined.

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Association of Adjuvant Therapy with Improved Survival in Ampullary Cancer: A National Cohort Study.

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Association of Adjuvant Therapy with Improved Survival in Ampullary Cancer: A National Cohort Study.

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