What is the role of stereotactic ablative radiotherapy in the management of surgically resectable and operable stage I non-small cell lung cancer?
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ABSTRACT:
SUBMITTER: Love SM
PROVIDER: S-EPMC5465166 | biostudies-literature | 2017 May
REPOSITORIES: biostudies-literature
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What is the role of stereotactic ablative radiotherapy in the management of surgically resectable and operable stage I non-small cell lung cancer?
Love Susannah M SM Hardman Gillian G Mashar Ruchir R Shah Rajesh D RD
Journal of thoracic disease 20170501 5
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Project description: Not available
| S-EPMC4828125 | biostudies-literature
Project description:Surgery is the gold therapeutic standard for patients affected with stage I non-small cell lung cancer. Stereotactic ablative radiotherapy is currently considered the preferred treatment option for inoperable patients, representing approximately 25%. Limited data are available directly comparing surgery and SABR in operable patients, none of them prospective. Preliminary results are encouraging, showing that the two treatment modalities are equally effective in terms of tumour control, with expected similar survival projections. Moreover, in elderly patients SABR could represent a valid treatment alternative in comparison to surgery due to the lower morbidity. We here review and discuss the potential role of SABR as an alternative to surgery in operable early stage lung cancer patients.
| S-EPMC4104015 | biostudies-literature
Project description:BackgroundThe standard of care for operable, stage I, non-small-cell lung cancer (NSCLC) is lobectomy with mediastinal lymph node dissection or sampling. Stereotactic ablative radiotherapy (SABR) for inoperable stage I NSCLC has shown promising results, but two independent, randomised, phase 3 trials of SABR in patients with operable stage I NSCLC (STARS and ROSEL) closed early due to slow accrual. We aimed to assess overall survival for SABR versus surgery by pooling data from these trials.MethodsEligible patients in the STARS and ROSEL studies were those with clinical T1-2a (<4 cm), N0M0, operable NSCLC. Patients were randomly assigned in a 1:1 ratio to SABR or lobectomy with mediastinal lymph node dissection or sampling. We did a pooled analysis in the intention-to-treat population using overall survival as the primary endpoint. Both trials are registered with ClinicalTrials.gov (STARS: NCT00840749; ROSEL: NCT00687986).Findings58 patients were enrolled and randomly assigned (31 to SABR and 27 to surgery). Median follow-up was 40·2 months (IQR 23·0-47·3) for the SABR group and 35·4 months (18·9-40·7) for the surgery group. Six patients in the surgery group died compared with one patient in the SABR group. Estimated overall survival at 3 years was 95% (95% CI 85-100) in the SABR group compared with 79% (64-97) in the surgery group (hazard ratio [HR] 0·14 [95% CI 0·017-1·190], log-rank p=0·037). Recurrence-free survival at 3 years was 86% (95% CI 74-100) in the SABR group and 80% (65-97) in the surgery group (HR 0·69 [95% CI 0·21-2·29], log-rank p=0·54). In the surgery group, one patient had regional nodal recurrence and two had distant metastases; in the SABR group, one patient had local recurrence, four had regional nodal recurrence, and one had distant metastases. Three (10%) patients in the SABR group had grade 3 treatment-related adverse events (three [10%] chest wall pain, two [6%] dyspnoea or cough, and one [3%] fatigue and rib fracture). No patients given SABR had grade 4 events or treatment-related death. In the surgery group, one (4%) patient died of surgical complications and 12 (44%) patients had grade 3-4 treatment-related adverse events. Grade 3 events occurring in more than one patient in the surgery group were dyspnoea (four [15%] patients), chest pain (four [15%] patients), and lung infections (two [7%]).InterpretationSABR could be an option for treating operable stage I NSCLC. Because of the small patient sample size and short follow-up, additional randomised studies comparing SABR with surgery in operable patients are warranted.FundingAccuray Inc, Netherlands Organisation for Health Research and Development, NCI Cancer Center Support, NCI Clinical and Translational Science Award.
| S-EPMC4489408 | biostudies-literature
Project description:Recently published data from pooled randomised trials conclude that stereotactic ablative radiotherapy (SABR) can be considered the treatment of choice in operable lung cancer patients fit for lobectomy. This conclusion comes for comparable 3-year survival and much lower risk of early severe morbidity and mortality. In this editorial comment we discuss the validity of the conclusions due to the prematurity of the survival analysis and to the poor accuracy of patients' staging leading to higher rates of regional relapse in the SABR arm. Besides, therapy-related mortality and morbidity in the pooled cohort is much higher that the internationally accepted standards maybe because surgery was not performed according to the best approaches and procedures currently available. The effectiveness of SABR as the sole therapy for resectable lung cancer is still awaiting for sound evidences. It could be adopted for individual cases only in two situations: (I) the patient does not accept surgical treatment; and (II) in cases were the risk of surgical related mortality is considered to exceed the probability of long-term survival after lung resection. For this, a multidisciplinary team (MDT) assessment, including surgeons and oncologists, is mandatory.
| S-EPMC4758969 | biostudies-literature
Project description:BackgroundAlthough the choice between stereotactic ablative radiotherapy (SABR) and lobectomy for early-stage non-small cell lung cancer (NSCLC) has been debated for years, the two procedures have not yet been directly compared in a randomized trial. We conducted a virtual randomized phase III trial stratified by age to compare the effectiveness of lobectomy and SABR for medically operable patients with stage IA (AJCC eighth) NSCLC using the Markov model analysis.MethodsA Markov model was developed to simulate a cohort of patients aged 45-85 years with stage IA NSCLC who had undergone either lobectomy or SABR and were followed up for their remaining lifetime. Each virtual patient was randomly assigned to undergo lobectomy or SABR, and 10 000 patients were allocated to each group. All estimates of the variables were obtained by a systematic review of published articles.ResultsThe lobectomy group showed a better life expectancy than the SABR group, in patients under 75 years of age. However, no statistically significant difference was seen in patients 75 years or older. The predicted life expectancy was 9.43 and 8.70 years in 75-year-old patients in the lobectomy and SABR groups, respectively. However, the 95%CI for the difference in life expectancy between the two groups was - 0.06-1.50 years (P = 0.0689).ConclusionsThe Markov model showed no statistically significant difference in the expected overall survival in stage IA NSCLC patients who were older than 75 years and had undergone SABR or lobectomy.
| S-EPMC6558457 | biostudies-literature
Project description:BACKGROUND:There is debate regarding the use of stereotactic ablative radiotherapy (SABR) or surgery for patients with early stage non-small cell lung cancer (NSCLC). This meta-analysis compared the clinical efficacy of SABR and lobectomy in stage I NSCLC patients. METHODS:An online search identified eight eligible articles (including 2 trials and 7 cohort studies) for inclusion. The odds ratio (OR) was used as a summary statistic. Overall survival (OS), cause-specific survival (CSS), and recurrence-free survival (RFS) were selected to calculate ORs with 95% confidence intervals (CI). Fixed-effects or random-effects models were conducted according to study heterogeneity. RESULTS:There were no significant differences between SABR and lobectomy in terms of one-year OS or CSS. Significant benefits of surgery were observed in three-year OS (OR 2.11, 95% CI 1.55-2.86), three-year CSS (OR 1.94, 95% CI 1.05-3.57), three-year RFS (OR 1.63, 95% CI 1.12-2.36), and five-year OS (OR 2.40, 95% CI 1.71-3.36). In addition, lobectomy demonstrated a beneficial trend in one-year RFS, five-year RFS, and CSS. CONCLUSION:Meta-analyses of current evidence suggested that lobectomy provides better long-term survival outcomes for stage I NSCLC patients.
| S-EPMC5832478 | biostudies-literature
Project description:BackgroundA previous pooled analysis of the STARS and ROSEL trials showed higher survival after stereotactic ablative radiotherapy (SABR) than with surgery for operable early-stage non-small-cell lung cancer (NSCLC), but that analysis had notable limitations. This study reports long-term results of the revised STARS trial, in which the SABR group was re-accrued with a larger sample size, along with a protocol-specified propensity-matched comparison with a prospectively registered, contemporary institutional cohort of patients who underwent video-assisted thoracoscopic surgical lobectomy with mediastinal lymph node dissection (VATS L-MLND).MethodsThis single-arm prospective trial was done at the University of Texas MD Anderson Cancer Center (Houston, TX, USA) and enrolled patients aged 18 years or older with a Zubrod performance status of 0-2, newly diagnosed and histologically confirmed NSCLC with N0M0 disease (squamous cell, adenocarcinoma, large cell, or NSCLC not otherwise specified), and a tumour diameter of 3 cm or less. This trial did not include patients from the previous pooled analysis. SABR dosing was 54 Gy in three fractions (for peripheral lesions) or 50 Gy in four fractions (for central tumours; simultaneous integrated boost to gross tumour totalling 60 Gy). The primary endpoint was the 3-year overall survival. For the propensity-matching analysis, we used a surgical cohort from the MD Anderson Department of Thoracic and Cardiovascular Surgery's prospectively registered, institutional review board-approved database of all patients with clinical stage I NSCLC who underwent VATS L-MLND during the period of enrolment in this trial. Non-inferiority could be claimed if the 3-year overall survival rate after SABR was lower than that after VATS L-MLND by 12% or less and the upper bound of the 95% CI of the hazard ratio (HR) was less than 1·965. Propensity matching consisted of determining a propensity score using a multivariable logistic regression model including several covariates (age, tumour size, histology, performance status, and the interaction of age and sex); based on the propensity scores, one patient in the SABR group was randomly matched with one patient in the VATS L-MLND group using a 5:1 digit greedy match algorithm. This study is registered with ClinicalTrials.gov, NCT02357992.FindingsBetween Sept 1, 2015, and Jan 31, 2017, 80 patients were enrolled and included in efficacy and safety analyses. Median follow-up time was 5·1 years (IQR 3·9-5·8). Overall survival was 91% (95% CI 85-98) at 3 years and 87% (79-95) at 5 years. SABR was tolerated well, with no grade 4-5 toxicity and one (1%) case each of grade 3 dyspnoea, grade 2 pneumonitis, and grade 2 lung fibrosis. No serious adverse events were recorded. Overall survival in the propensity-matched VATS L-MLND cohort was 91% (95% CI 85-98) at 3 years and 84% (76-93) at 5 years. Non-inferiority was claimed since the 3-year overall survival after SABR was not lower than that observed in the VATS L-MLND group. There was no significant difference in overall survival between the two patient cohorts (hazard ratio 0·86 [95% CI 0·45-1·65], p=0·65) from a multivariable analysis.InterpretationLong-term survival after SABR is non-inferior to VATS L-MLND for operable stage IA NSCLC. SABR remains promising for such cases but multidisciplinary management is strongly recommended.FundingVarian Medical Systems and US National Cancer Institute (National Institutes of Health).
| S-EPMC8521627 | biostudies-literature
Project description:ImportanceThe incidence of early-stage non-small cell lung cancer (NSCLC) among the elderly is expected to rise dramatically owing to demographic trends and increased computed tomographic screening. However, to our knowledge, no modern trials have compared the most common treatments for NSCLC.ObjectiveTo determine clinical characteristics and survival outcomes associated with the 3 most commonly used definitive therapies for early-stage NSCLC in the elderly.Design, setting, and participantsThe Surveillance, Epidemiology, and End Results database linked to Medicare was used to determine the baseline characteristics and outcomes of 9093 patients with early-stage, node-negative NSCLC who underwent definitive treatment consisting of lobectomy, sublobar resection, or stereotactic ablative radiotherapy (SABR) from January 1, 2003, through December 31, 2009.Main outcomes and measuresOverall and lung cancer-specific survival were compared using Medicare claims through December 31, 2012. We used proportional hazards regression and propensity score matching to adjust outcomes for key patient, tumor, and practice environment factors.ResultsThe median age was 75 years, and treatment distribution was 79.3% for lobectomy, 16.5% for sublobar resection, and 4.2% for SABR. Unadjusted 90-day mortality was highest for lobectomy (4.0%) followed by sublobar resection (3.7%; P = .79) and SABR (1.3%; P = .008). At 3 years, unadjusted mortality was lowest for lobectomy (25.0%), followed by sublobar resection (35.3%; P < .001) and SABR (45.1%; P < .001). Proportional hazards regression demonstrated that sublobar resection was associated with worse overall survival (adjusted hazard ratio [AHR], 1.32 [95% CI, 1.20-1.44]; P < .001) and lung cancer-specific survival (AHR, 1.50 [95% CI, 1.29-1.75]; P < .001) compared with lobectomy. Propensity score-matching analysis reiterated these findings for overall survival (AHR, 1.36 [95% CI, 1.17-1.58]; P < .001) and lung cancer-specific survival (AHR, 1.46 [95% CI, 1.13-1.90]; P = .004). In proportional hazards regression, SABR was associated with better overall survival than lobectomy in the first 6 months after diagnosis (AHR, 0.45 [95% CI, 0.27-0.75]; P < .001) but worse survival thereafter (AHR, 1.66 [95% CI, 1.39-1.99]; P < .001). Propensity score-matching analysis of well-matched SABR and lobectomy cohorts demonstrated similar overall survival in both groups (AHR, 1.01 [95% CI, 0.74-1.38]; P = .94).Conclusions and relevanceLobectomy was associated with better outcomes than sublobar resection in elderly patients with early-stage NSCLC. Propensity score matching suggests that SABR may be a good option among patients with very advanced age and multiple comorbidities.
| S-EPMC4401470 | biostudies-literature
Project description:The prevalence of small cell lung cancer (SCLC) has declined in the U.S. as the prevalence of tobacco use has declined. However, a significant number of people in the U.S. are current or former smokers and are at risk of developing SCLC. Routine histological or cytological evaluation can reliably make the diagnosis of SCLC, and immunohistochemistry stains (thyroid transcription factor-1, chromogranin, synaptophysin, and CD56) can be used if there is uncertainty about the diagnosis. Rarely do patients present with SCLC amendable to surgical resection, and evaluation requires a meticulous workup for extra-thoracic metastases and invasive staging of the mediastinum. Resected patients require adjuvant chemotherapy and/or thoracic radiation therapy (TRT), and prophylactic cranial radiation (PCI) should be considered depending on the stage. For limited-stage disease, concurrent platinum-etoposide and TRT followed by PCI is the standard. Thoracic radiation therapy should be started early in treatment, and can be given twice daily to 45 Gy or once daily to 60-70 Gy. For extensive-stage disease, platinum-etoposide remains the standard first-line therapy, and the standard second-line therapy is topotecan. Preliminary studies have demonstrated the activity of immunotherapy, and the response rate is approximately 10-30% with some durable responses observed. Rovalpituzumab tesirine, an antibody drug conjugate, has shown promising activity in patients with high delta-like protein 3 tumor expression (approximately 70% of patients with SCLC). The emergence of these and other promising agents has rekindled interest in drug development in SCLC. Several ongoing trials are investigating novel agents in the first-line, maintenance, and second-line settings.Implications for practiceThis review will provide an update on the standard therapies for surgically resected limited-stage small cell lung cancer and extensive-stage small cell lung cancer that have been investigated in recent clinical trials.
| S-EPMC5728020 | biostudies-literature
Project description:PurposeStereotactic ablative radiotherapy (SABR) is an effective emerging technique for early-stage non-small cell lung cancer (NSCLC). We investigated the current practice of SABR for early-stage NSCLC in Korea.Materials and methodsWe conducted a nationwide survey of SABR for NSCLC by sending e-mails to all board-certified members of the Korean Society for Radiation Oncology. The survey included 23 questions focusing on the technical aspects of SABR and 18 questions seeking the participants' opinions on specific clinical scenarios in the use of SABR for early-stage NSCLC. Overall, 79 radiation oncologists at 61/85 specialist hospitals in Korea (71.8%) responded to the survey.ResultsSABR was used at 33 institutions (54%) to treat NSCLC. Regarding technical aspects, the most common planning methods were the rotational intensity-modulated technique (59%) and the static intensity-modulated technique (49%). Respiratory motion was managed by gating (54%) or abdominal compression (51%), and 86% of the planning scans were obtained using 4-dimensional computed tomography. In the clinical scenarios, the most commonly chosen fractionation schedule for peripherally located T1 NSCLC was 60 Gy in four fractions. For centrally located tumors and T2 NSCLC, the oncologists tended to avoid SABR for radiotherapy, and extended the fractionation schedule.ConclusionThe results of our survey indicated that SABR is increasingly being used to treat NSCLC in Korea. However, there were wide variations in the technical protocols and fractionation schedules of SABR for early-stage NSCLC among institutions. Standardization of SABR is necessary before implementing nationwide, multicenter, randomized studies.
| S-EPMC5512364 | biostudies-literature