Survival and treatment of non-small cell lung cancer stage I-II treated surgically or with stereotactic body radiotherapy: patient and tumor-specific factors affect the prognosis.

BACKGROUND: This study was designed to define clinical baseline parameters associated with impaired survival of patients with stage I or II non-small cell lung cancer (NSCLC) who underwent surgery or stereotactic body radiotherapy (SBRT). METHODS: From January 2001 to January 2011, 425 patients (216 surgery, 209 SBRT) were identified with clinical stage I or II NSCLC. Cox proportional-hazards regression analyses were used to investigate risk factors for mortality. RESULTS: Median age of patients in the surgery and SBRT groups was 65 and 74 years, respectively. A smaller proportion of the surgical group had Charlson Comorbidity Index (CCI) score ≥1 compared with the SBRT group: 52 and 72 % (p < 0.001), respectively. Overall survival in the surgical group at 2 and 4 years was 79 and 65 %, respectively. In the SBRT group, this was 65 % at 2 years and 44 % at 4 years. In the surgical group older age, CCI score = 4 and clinical stage = IIB were associated with long-term mortality. In the SBRT group, this was CCI score ≥5 and clinical stage >IA. The area under the curve was calculated for the model with clinical and tumor factors: 0.77 for the surgery and 0.85 for the SBRT group. CONCLUSIONS: Both patient characteristics and survival of NSCLC I-II patients undergoing surgical treatment or SBRT differ considerably. Long-term survival as a result of treatment strategy of NSCLC patients might be optimized by focusing on patient and tumor specific factors. In addition to TNM staging, the consideration of patient age and CCI can be useful for prognostication of NSCLC patients.

Evidence-Based and Personalized Medicine. It's [AND] not [OR].

Good clinical practice is an amalgamation of personalized medicine with evidence-based medicine in the best interests of patient. Hence, our title uses Boolean operators to indicate that it is [AND] not [OR]. This is the syntax of formal searching for systematic reviews, ensuring that all the evidence is found. Comprehensive evidence-based guidance can thus be formulated. Many residents and fellows around the world, and their chiefs, are now exposed to consensus documents, white papers, levels of appropriateness, and guidelines and are in many jurisdictions expected to comply with them. However, they are the summation of many forms of evidence, each of which has its place, and we consider them in turn in this article.

Opinions of lung cancer clinicians on shared decision making in early-stage non-small-cell lung cancer.

OBJECTIVES: To investigate the opinions of lung cancer clinicians concerning shared decision making (SDM) in early-stage non-small-cell lung cancer patients. METHODS: A survey was conducted among Dutch cardiothoracic surgeons and lung surgeons, pulmonologists and radiation oncologists. The opinions of clinicians on the involvement of patients in treatment decision making was assessed using a 1-5 Likert-type scale. Through open questions, we queried barriers to and drivers of SDM in clinical practice. Clinicians were asked to review 7 hypothetical cases and indicate which treatment strategy they would choose using a 1-7 Likert-type scale. RESULTS: Twenty-six percent of surgeons, 20% of pulmonologists and 12% of radiation oncologists indicated that they always engage in SDM (16% missing; P-value = 0.10). Most respondents stated that, ideally, doctors and patients should decide together (surgeons 52%, pulmonologists 67% and radiation oncologists 35%; P-value = 0.005). Thirty percent of surgeons, 27% of pulmonologists and 44% of radiation oncologists indicated that doctors are not properly trained to implement SDM in clinical practice (P-value = 0.37). SDM may not always be feasible due to low patient education level and minimal knowledge about lung cancer. Wide variations in the clinicians' lung cancer treatment preferences were observed in the responses to the hypothetical cases. CONCLUSIONS: In current clinical decision making in lung cancer treatment, a majority of clinicians agree that it is important to involve lung cancer patients in treatment decision making but that time constraints and the inability of some patients to make a weighted decision are important barriers. The observed variation in lung cancer treatment preferences among clinicians suggests that for most patients both surgery and radiotherapy are suitable options, and it underlines the sensitive nature of treatment choices in early-stage non-small-cell lung cancer.

Systematic lymphadenectomy versus sampling of ipsilateral mediastinal lymph-nodes during lobectomy for non-small-cell lung cancer: a systematic review of randomized trials and a meta-analysis.

OBJECTIVES: To re-examine the evidence for recommendations for complete dissection versus sampling of ipsilateral mediastinal lymph nodes during lobectomy for cancer. METHODS: We searched for randomized trials of systematic mediastinal lymphadenectomy versus mediastinal sampling. We performed a textual analysis of the authors' own starting assumptions and conclusion. We analysed the trial designs and risk of bias. We extracted data on early mortality, perioperative complications, overall survival, local recurrence and distant recurrence for meta-analysis. RESULTS: We found five randomized controlled trials recruiting 1980 patients spanning 1989-2007. The expressed starting position in 3/5 studies was a conviction that systematic dissection was effective. Long-term survival was better with lymphadenectomy compared with sampling (Hazard Ratio 0.78; 95% CI 0.69-0.89) as was perioperative survival (Odds Ratio 0.59; 95% CI 0.25-1.36, non-significant). But there was an overall high risk of bias and a lack of intention to treat analysis. There were higher rates (non-significant) of perioperative complications including bleeding, chylothorax and recurrent nerve palsy with lymphadenectomy. CONCLUSIONS: The high risk of bias in these trials makes the overall conclusion insecure. The finding of clinically important surgically related morbidities but lower perioperative mortality with lymphadenectomy seems inconsistent. The multiple variables in patients, cancers and available treatments suggest that large pragmatic multicentre trials, testing currently available strategies, are the best way to find out which are more effective. The number of patients affected with lung cancer makes trials feasible.

Quality of life during 5 years after stereotactic radiotherapy in stage I non-small cell lung cancer.

PURPOSE: To determine the long-term impact of stereotactic radiotherapy (SRT) on the quality of life (QoL) of inoperable patients with early-stage non-small cell lung cancer (NSCLC). METHODS AND MATERIALS: From January 2006 to February 2008, 39 patients with pathologically confirmed T1-2N0M0 NSCLC were treated with SRT. QoL, overall survival and local tumor control were assessed. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30 and the lung cancer-specific questionnaire QLQ-LC13 were used to investigate changes in QoL. Assessments were done before treatment, at 3 weeks, every 2-3 months during the first two years, and then every 6 months until 5 years after the treatment or death or progressive disease. The median follow up was 38 months. RESULTS: During the 5 years after treatment with SRT for stage I NSCLC, the level of QoL was maintained: There was a slow decline (slope: -0.015) of the global health status over the 5 years (p < 0.0001). The physical functioning and the role functioning improved slowly (slope: 0.006 and 0.004, resp.) over the years and this was also significant (p < 0.0001). The emotional functioning (EF) improved significantly at 1 year compared to the baseline. Two years after the treatment dyspnea slowly increased (slope: 0.005, p = 0.006). The actuarial overall survival was 62% at 2 years and 31% at 5-years. CONCLUSION: QoL was maintained 5 years after SRT for stage I NSCLC and EF improved significantly. Dyspnea slowly increased 2 years after the treatment.

Comparison of clinical outcome of stage I non-small cell lung cancer treated surgically or with stereotactic radiotherapy: results from propensity score analysis.

OBJECTIVES: Guideline-specified curative therapies for a clinical stage I non-small cell lung cancer (NSCLC) are either lobectomy or Stereotactic Ablative Radiotherapy (SABR). As outcomes of prospective randomized clinical trials comparing these modalities are unavailable, we performed a propensity-score matched analysis to create two similar groups in order to compare clinical outcomes. METHODS: We selected 577 patients, 96 VATS or open lobectomy were treated at Erasmus University Medical Center Rotterdam and 481 SABR patients were treated at VU University Medical Center Amsterdam with clinical stage I NSCLC. RESULTS: Matching of patients according to propensity score resulted in a cohort that consisted of 73 patients in the surgery group and of 73 patients in the SABR group. Median follow-up in the surgery and SABR group was 49 months and 28 months, respectively. Overall survival of patients who underwent surgery was 95% and 80% at 12 and 60 months, respectively. For the SABR group this was 94% at 12 months and 53% at 60 months. No statistical significant difference (p=0.089) in survival was found between these groups. CONCLUSIONS: In this study we found no significant differences in overall survival in propensity matched patients diagnosed with stage I NSCLC treated either surgically or with SABR. After 3 years there seems to be a trend toward improved survival in patients who were treated surgically.

Predicting Overall Survival After Stereotactic Ablative Radiation Therapy in Early-Stage Lung Cancer: Development and External Validation of the Amsterdam Prognostic Model.

PURPOSE: A prognostic model for 5-year overall survival (OS), consisting of recursive partitioning analysis (RPA) and a nomogram, was developed for patients with early-stage non-small cell lung cancer (ES-NSCLC) treated with stereotactic ablative radiation therapy (SABR). METHODS AND MATERIALS: A primary dataset of 703 ES-NSCLC SABR patients was randomly divided into a training (67%) and an internal validation (33%) dataset. In the former group, 21 unique parameters consisting of patient, treatment, and tumor factors were entered into an RPA model to predict OS. Univariate and multivariate models were constructed for RPA-selected factors to evaluate their relationship with OS. A nomogram for OS was constructed based on factors significant in multivariate modeling and validated with calibration plots. Both the RPA and the nomogram were externally validated in independent surgical (n = 193) and SABR (n = 543) datasets. RESULTS: RPA identified 2 distinct risk classes based on tumor diameter, age, World Health Organization performance status (PS) and Charlson comorbidity index. This RPA had moderate discrimination in SABR datasets (c-index range: 0.52-0.60) but was of limited value in the surgical validation cohort. The nomogram predicting OS included smoking history in addition to RPA-identified factors. In contrast to RPA, validation of the nomogram performed well in internal validation (r(2) = 0.97) and external SABR (r(2) = 0.79) and surgical cohorts (r(2) = 0.91). CONCLUSIONS: The Amsterdam prognostic model is the first externally validated prognostication tool for OS in ES-NSCLC treated with SABR available to individualize patient decision making. The nomogram retained strong performance across surgical and SABR external validation datasets. RPA performance was poor in surgical patients, suggesting that 2 different distinct patient populations are being treated with these 2 effective modalities.