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Biomarkers for efficacy of adjuvant chemotherapy following complete resection in NSCLC stages I-IIIA.

ABSTRACT: Biomarkers may be useful when deciding which nonsmall cell lung cancer (NSCLC) patients may benefit from adjuvant chemotherapy following complete resection and which chemotherapeutic agents may be used preferably in individual patients in order to maximise survival. A literature search covering the period from 2003 to May, 2014 was conducted using PubMed and the following search terms: "non-small cell lung cancer", "NSCLC", "adjuvant chemotherapy", "randomized", "randomised", "biomarkers", "prognostic", "predictive". This review focuses on current knowledge of biomarkers for prognosis or efficacy of adjuvant treatment following complete resection in stage I-IIIA NSCLC patients. This review includes results on 18 different biomarkers and five gene profiles. A statistically significant prognostic impact was reported for: iNTR, TUBB3, RRM1, ERCC1, BRCA1, p53, MRP2, MSH2, TS, mucin, BAG-1, pERK1/2, pAkt-1, microRNA, TopIIA, 15-gene profile, 92-gene profile, 31-gene profile and 14-gene profile. A statistically significant predictive impact was reported for: ERCC1, p53, MSH2, p27, TUBB3, PARP1, ATM, 37-gene profile, 31-gene profile, 15-gene profile and 92-gene profile. Uncertainties regarding the optimal analysis method and cut-off levels for the individual markers may blur the prognostic or predictive signals. None of the possible predictive markers have been validated in prospective trials. Thus, there are no biomarkers ready to use in an adjuvant setting in NSCLC.

SUBMITTER: Wallerek S

PROVIDER: S-EPMC9487808 | biostudies-literature | 2015 Jun

REPOSITORIES: biostudies-literature

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Biomarkers for efficacy of adjuvant chemotherapy following complete resection in NSCLC stages I-IIIA.

Wallerek Sandra S Sørensen Jens Benn JB

European respiratory review : an official journal of the European Respiratory Society 20150601 136

Biomarkers may be useful when deciding which nonsmall cell lung cancer (NSCLC) patients may benefit from adjuvant chemotherapy following complete resection and which chemotherapeutic agents may be used preferably in individual patients in order to maximise survival. A literature search covering the period from 2003 to May, 2014 was conducted using PubMed and the following search terms: "non-small cell lung cancer", "NSCLC", "adjuvant chemotherapy", "randomized", "randomised", "biomarkers", "prog ...[more]

PMID: 26028645

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Project description:Background Atezolizumab was first shown to significantly improve progression-free survival (PFS) after platinum-based chemotherapy in early-stage non-small cell lung cancer (NSCLC) in the IMpower010 Phase 3 trial. However, the cost-effectiveness and potential economic impact of atezolizumab treatment in Chinese patients are unknown. Methods Markov models were constructed based on follow-up data from the IMpower010 trial and assessed separately in the programmed cell death receptor ligand-1 (PD-L1) tumor cells (TC) ≥ 1% stage II – IIIA group, all stage II – IIIA groups, and the intention-to-treat (ITT) group (stage IB–IIIA). Efficacy and safety data were obtained from the IMpower010 trial, and costs and utility values were derived from the literature and local surveys to estimate their incremental cost-effectiveness ratios (ICERs) compared with willingness-to-pay (WTP) thresholds in scenarios implementing patient assistance programs (PAP) or drug price negotiations. Univariate sensitivity analysis and probabilistic sensitivity analysis (PSA) were performed to investigate the stability of the model results. Results Compared with best supportive care (BSC), atezolizumab produced an additional 0.45 quality-adjusted life-years (QALYs), 0.04 QALYs, and -0.0028 QALYs in the PD-L1 TC ≥ 1% stage II – IIIA group, all stage II – IIIA groups, and the ITT group, and the ICERs were 108,825.37/QALY, 1,028,538.22/QALY, and -14,381,171.55/QALY, respectively. The ICERs all exceeded the WTP threshold of $27,354 per QALY (three times the per capita gross domestic product of China in 2022), and univariate sensitivity analysis showed that the price of atezolizumab played a crucial role in the model results. PSA showed that the probability of cost-effectiveness of atezolizumab in the PD-L1 TC ≥ 1% stage II – IIIA group, all stage II – IIIA groups, and the ITT group increased with the increasing WTP threshold. Conclusion From the perspective of China’s health care system, in the PD-L1 TC ≥ 1% stage II – IIIA group, all stage II – IIIA groups, and the ITT group, the use of atezolizumab in the adjuvant treatment of patients with early-stage NSCLC after platinum-based chemotherapy is unlikely to be cost-effective. The implementation of PAP or price reduction negotiations for atezolizumab might be among the most effective measures to improve its cost-effectiveness.

Project description:Importance:Adjuvant chemotherapy (AC) in patients with rectal cancer with pathologic complete response following neoadjuvant chemoradiotherapy (nCRT) and resection is recommended by treatment guidelines. However, its role in this setting is equivocal because data supporting benefits are lacking. Objective:To compare the overall survival (OS) between AC and postoperative observation (OB) in patients with rectal cancer with pathologic complete response following nCRT and resection. Design, Setting, and Participants:We identified a cohort of patients with rectal cancer and a complete pathological response (ypT0N0) after nCRT in the National Cancer Database between 2006 and 2012. Patients who received AC were compared with OB patients by propensity score matching. Overall survival was compared using the stratified log-rank test and stratified Cox regression model. The outcomes after AC vs OB were also evaluated in patient subgroups. The data analysis was completed in June 2017. Exposures:Adjuvant chemotherapy and OB. Main Outcomes and Measures:Overall survival. Results:We identified 2764 patients (mean [SD] age, 60.0 [12.3] years; 40% female) with clinical stage II or III resected adenocarcinoma of the rectum who had received nCRT and were complete responders (ypT0N0M0). Of this cohort, 741 patients in the AC group were matched by propensity score to 741 patients who underwent OB. The AC cohort had better OS compared with the OB cohort (hazard ratio, 0.50; 95% CI, 0.32-0.79). The 1-, 3-, and 5-year OS rates were 99.7%, 97.1%, and 94.7% for the AC group and 99.2%, 93.6%, and 88.4% for the OB group (P = .005). In subgroup analysis, patients with clinical stage T3/T4 and node-positive disease benefited most from AC (hazard ratio, 0.47; 95% CI, 0.25-0.91). Conclusions and Relevance:Adjuvant chemotherapy was associated with improved OS in patients with pathologic complete response after nCRT for resected locally advanced rectal cancer. This study supports the use of AC in this setting where there is currently paucity of data.

Project description:ObjectiveConcern exists regarding surgery after thoracic radiation. We aimed to assess early results of anatomic resection following induction therapy with platinum-based chemotherapy and full-dose thoracic radiation for resectable N2+ stage IIIA non-small cell lung cancer.MethodsTwo prospective trials were recently conducted by NRG Oncology in patients with resectable N2+ stage IIIA non-small cell lung cancer with the primary end point of mediastinal node sterilization following concurrent full-dose chemoradiotherapy (Radiation Therapy Oncology Group trials 0229 and 0839). All surgeons demonstrated postinduction resection expertise. Induction consisted of weekly carboplatin (area under the curve, 2.0) and paclitaxel (50 mg/m2) and concurrent thoracic radiation 60 Gy (0839)/61.2 Gy (0229) in 30 fractions. Patients in study 0839 were randomized 2:1 to weekly panitumumab + chemoradiotherapy or chemoradiotherapy alone during induction. Primary results were similar in all treatment arms and reported previously. Short-term surgical outcomes are reported here.ResultsOne hundred twenty-six patients enrolled; 93 (74%) had anatomic resection, 77 underwent lobectomy, and 16 underwent extended resection. Microscopically margin-negative resections occurred in 85 (91%). Fourteen (15%) resections were attempted minimally invasively, including 2 converted without event. Grade 3 or 4 surgical adverse events were reported in 26 (28%), 30-day mortality in 4 (4%) and 90-day mortality in 5 (5%). Patients undergoing extended resection experienced similar rates of grade 3 or 4 adverse events (odds ratio, 0.95; 95% confidence interval, 0.42-3.8) but higher 30-day (1.3% vs 18.8%) (odds ratio, 17.54; 95% confidence interval, 1.75-181.8) and 90-day mortality (2.6% vs 18.8%) (odds ratio, 8.65; 95% confidence interval, 1.3-56.9).ConclusionsLobectomy was performed safely following full-dose concurrent chemoradiotherapy in these multi-institutional prospective trials; however, increased mortality was noted with extended resections.

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Biomarkers for efficacy of adjuvant chemotherapy following complete resection in NSCLC stages I-IIIA.

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Biomarkers for efficacy of adjuvant chemotherapy following complete resection in NSCLC stages I-IIIA.

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