Background: With the increased use of neoadjuvant chemotherapy (NAC), as well as increasing efficacy of systemic therapy, a substantial proportion of clinically nodepositive patients may achieve a nodal pathologic complete response (pCR) with chemotherapy. Instead of axillary lymph node dissection (ALND), a novel surgical technique called targeted axillary dissection (TAD) including removal of sentinel lymph nodes (SLNs) and clip-marked node has been gaining acceptance in recent years. Logically, preoperative identification of patients with pCR or residual disease would allow for the optimization of axillary surgery for performing a TAD or proceeding to a ALND after NAC, thus sparing patients unnecessary procedures or expense. The aim of this study was to investigate the value of 18 F-FDG PET/CT in tailoring axillary surgery by predicting nodal response among node-positive breast cancer patients after NAC. Methods: Breast cancer patients with biopsy-confirmed nodal metastasis were prospectively enrolled. At least one 18 F-FDG PET/CT scan was performed before NAC (a second one after two cycles with baseline SUV max in axillary lymph nodes 2.5), among whom a subset of patients had underwent TAD. All the patients ultimately underwent ALND. The accuracy was calculated by a comparison with the final pathologic results. Results: Table . Accuracy of 18 F-FDG PET/CT to Predict Ax-pCR in Overall Population and Different Subtypes Overall population ER-HER2þ subtype The rest subtypes No. of patients 111 31 80 Ax-pCR rate (%) 55.

No abstract

Scoring on ASCO and ESMO frameworks for 102 advanced oncology drugs were taken from Cherny 2018. Corresponding final appraisal documents by NICE were reviewed. Data were extracted for indication, comparators, clinical benefit assessment, toxicity, quality of life, and cost-effectiveness. NICE committee's final decision was recorded: recommended or not, with restriction in indication or with a patient access scheme (PAS) or on the cancer drugs fund (CDF). The relationship between ASCO/ESMO scores and NICE recommendation was investigated. Results: 79% of the 102 drugs included in Cherny 2018 were assessed by NICE; 45% were recommended by NICE, 22% were with PAS and 12% on the CDF. Of the recommended treatments, 82% and 93% were associated with a moderate to high clinical benefit score on ASCO (.40) and ESMO (.3), respectively. Treatments with restricted recommendation based on indication and on CDF were associated with the highest mean ASCO (54) and ESMO (4) benefit score. Cost-effectiveness was less correlated with clinical scoring, potentially suggesting that pricing does not fully reflect clinical benefit. The cost-effectiveness analysis was limited by the confidential nature of the final agreed price. Conclusions: An association was found between NICE recommendations and clinical benefit assessments by ASCO and ESMO despite the difference in performance criteria, clinical evidence, comparator choice, disease burden, and cost-effectiveness, adopted by payers and clinical frameworks.

und Wirtschaftlichkeit im Gesundheitswesen, IQWiG) assesses the benefits and harms of new drugs. IQWiG's guidelines specify that ratings of individual outcomes are based on the upper limit of confidence intervals thresholds of hazard ratio. In oncology, benefit in mortality typically drives the overall benefit, but other outcomes may also impact IQWIG's overall benefit rating. The objective was to identify what additional clinical outcomes may impact IQWIG's HTA decision-making in oncology. Oncology drug assessments from 2011-2018 were identified through the IQWiG website. Reported outcomes were reviewed in line with IQWiG's categorization overall survival (OS), safety, morbidity and HRQoL. The extent of benefit or harm of each individual outcome was correlated by category and subsequently to the overall benefit rating. 92 IQWIG oncology drug assessments covering 168 different subgroups were identified. In 116 of 168, the overall benefit rating matched the mortality benefit rating. For the 52 subgroups where overall ratings did not match mortality benefit rating, data on safety, morbidity and/or HRQoL drove a higher or lower benefit rating (18 and 34 subgroups, respectively). 'Major clinical benefits' in these outcome categories were correlated with a higher overall benefit rating as seen in 12 of the 18 subgroups with higher benefit ratings. Only for 1 subgroup did a 'major clinical benefit' not translate in a higher overall rating. In 5 out of 6 subgroups receiving a higher overall benefit rating without 'major clinical benefits', some extent of benefit in safety outcomes were identified. Mortality remains the main decision driver in IQWiG overall benefit rating for oncology. When no OS benefit can be demonstrated, or when additional data is available, a major benefit in safety, morbidity or HRQoL, is likely to lead a more favorable overall IQWiG rating.

Sir, With reference to the study by Ward et al (2006), the article compares the cost effectiveness of oral fluoropyrimidine treatment for mCRC vs intravenously administered therapies. In particular, this paper compares Uftoral s (tegafur-uracil), with capecitabine, based on unit costs for drugs as outlined in the British National Formulary, 2002. However, there are a number of discrepancies we would like to highlight with this assessment. First, as of March 2006 the price of Uftoral s (tegafur-uracil) was reduced as indicated in the following table: