Background The magnitude of clinical benefit of solid cancer drugs can be standardly assessed via the Magnitude of Clinical Benefit Scale (MCBS) developed by the European Society for Medical Oncology (ESMO). We applied two ESMO-MCBS versions to the last 12 years of European cancer drug approval and compared two predefined marketing authorisation timeframes to identify potential score changes over time. Material and methods Originator solid cancer drugs and indication extensions that were approved between 1 January 2009 and 31 October 2020 by the European Medicines Agency (EMA) were included in our analyses. To evaluate the clinical benefit of these cancer indications, the original ESMO-MCBS (v 1.1) and a locally adapted ESMO-MCBS version were applied to the study sample. Thus, two ESMO-MCBS versions were compared, and an additional analysis was conducted to identify potential score differences between two approval timeframes 2009-2014 versus 2015-2020. Results A total of 144 cancer indications intended as curative ( n = 9) or non-curative ( n = 135) treatment options were eligible for an ESMO-MCBS assessment. Solely a minority of the assessed cancer indications met the meaningful clinical benefit (MCB) criteria independent of the applied version of the scale and treatment intention (original: n = 48/144, 33.3% versus adapted: n = 27/144, 18.8%). Comparing the two EMA approval timeframes, a growing number of approved cancer indications could be observed: 2009-2014: n = 9/year versus 2015-2020: n = 14/year. In addition, almost no difference in the proportion of cancer indications that have met the MCB criteria was detectable when comparing the predefined authorisation timeframes (MCB increase original: +4.1% and adapted: +3.9%). Conclusion Applying both versions of the ESMO-MCBS can help to identify potentially beneficial cancer indications, but also those with rather uncertain or low clinical benefit and thus, support the fair allocation of limited health care resources.
Health-related quality of life (HRQoL) is one of the most important patient-relevant study end-points for the direct measurement of the benefit of cancer drugs. Therefore, our aim is to detect cancer indications with no published information on HRQoL at the time of European Medicines Agency (EMA) approval and monitor any reported HRQoL evidence updates after at least three years of follow-up. Methods: We included all cancer indications that were approved by the EMA between January 2009 and October 2015. Our main sources of information were the EMA website, clinicaltrials.gov and a systematic literature search in PubMed. Information on HRQoL outcomes was extracted alongside evidence on median overall survival. Results: In total, we identified 110 indications, of which more than half (n Z 58, 53%) were lacking available information on HRQoL assessments at the time of EMA approval. After a monitoring period of at least three years, 24 updates were identified, resulting in 34 (31%) therapies where information on HRQoL was still not available. For the 76 therapies with reported information on HRQoL, cancer-specific instruments were mostly used (n Z 49/ 76). Regarding cumulative evidence on median overall survival and HRQoL, 33 (n Z 33/ 110, 30%) as well as 15 (n Z 15/110, 14%) cancer drugs were lacking information on both study end-points at the time of approval and after monitoring, respectively. Conclusion: Our results demonstrate that there is an urgent need of routine re-evaluation of reimbursed cancer drugs with initially missing information on major outcomes.
Laparoscopy is one of the most common surgical procedures in gynecologic medicine. Major complications associated with gynecologic laparoscopy are relatively rare, with up to 50% related to laparoscopic entry. Several entry techniques have been developed, all of which aim to provide a safe and easy entry to the abdominal cavity. In this article, we aim to review the available evidence on laparoscopic entry techniques in gynecologic surgery. We found no evidence that the Hasson (open) technique is superior to the Veress needle entry, the preferred method of most gynecologists all over the world. When entering the abdomen using the Veress needle, an intraperitoneal pressure <10 mmHg is a reliable predictor of correct intraperitoneal placement. Entry at Palmer's point (left upper quadrant laparoscopy) is recommended for patients with suspected or known periumbilical adhesions, or a history or presence of umbilical hernia, or after three failed insufflation attempts at the umbilicus. Recently published trials suggest that direct trocar entry, especially when using optical trocar systems, might be superior to both the Hasson open technique and the Veress needle entry to avoid extraperitoneal insufflation and failed entry. Moreover, blood loss can be reduced and the mean entry time shortened. Laparoscopic entry techniques are still a controversial topic in gynecologic surgery. Many studies are underpowered in order to assess the risk for rare but lifethreatening complications. In conclusion, there is no solid evidence proving the superiority of any method of laparoscopic entry.
Aim To summarize the evidence on the clinical effectiveness and safety of coronary sinus reducing stent (CSRS) therapy in refractory angina pectoris (AP) patients. Methods We performed a systematic literature search in common databases (n=4). The evidence obtained was summarized according to GRADE methodology. A health technology assessment (HTA) was conducted using the HTA Core Model ® for Rapid Relative Effectiveness Assessment. Primary outcomes for the clinical effectiveness domain were the proportion of patients with improvement in two or more Canadian Cardiovascular Society (CCS) angina score classes, overall mean reduction of CCS class, and Seattle Angina Questionnaire (SAQ) quality of life (QoL) score improvement. Outcomes for the safety domain were adverse device effects (ADEs) and serious adverse device effects (SADEs). Results One randomized controlled trial (RCT) was identified. Outcomes that showed statistically significant differences between CSRS and sham treatment (in favor of CSRS) were CCS angina score improvement of one or two classes, overall mean reduction of CCS class, and SAQ QoL score improvement. Concerning safety, the sham-controlled trial data indicate that there were fewer SADEs in the intervention group (19%) than in the control group (46%). SADEs reported in observation studies ranged from none to 30%. The most frequently reported SADEs were death and stable angina. In the RCT, the only case of death occurred in the control group. Concerning clinical effectiveness, the risk of bias (RoB) was rated to be low, and concerning safety, the RoB was rated to range from low to moderate. As assessed by GRADE, the overall strength of evidence for effectiveness and safety was moderate. Internal and external validity of the evidence base were low. Conclusion Even though the current evidence indicates that the assessed technology, CSRS, is potentially more effective than sham intervention for refractory AP patients, the lack of internal validity of the studies undermines the partially positive results.
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