Objective tumor response may be underestimated by RECIST criteria, since biological agents can cause metabolic response (necrosis) not related to tumor size. For this reason, CHOI criteria were ...designed to evaluate both tumor density and size. We compared CHOI and RECIST criteria in evaluating response to sorafenib in patients with advanced STS, treated within a phase II trial. The objective was to compare CHOI and RECIST criteria and to relate response to progression-free (PFS) and overall survival (OS).
Sixty one advanced STS patients received sorafenib 400 mg twice daily for progressive or relapsed disease after anthracycline-based chemotherapy. Treatment was continued until progression or major toxicity. Contrast-enhanced CT was performed every 3 months. Thirty patients were evaluable for response, according to both RECIST and CHOI criteria.
A total of 30 patients were included in the analysis. According to RECIST, we observed 1 (3%) complete response (CR), 1 (3%) partial remission (PR), 18 (60%) stable diseases (SD) and 10 (34%) progressive diseases (PD) at 3 months. According to CHOI, we observed 1 (3%) CR, 10 (34%) PR, 5 (16%) SD and 14 (47%) PD. The agreement between the two techniques was low (cohen Kappa: 0.36; CI 95%, 0.17-0.55). Of the 18 pts with SD according to RECIST, a total of 13 (72%) pts were reallocated to responder (8 PR, 44%) and non-responder (5 PD, 28%) groups, while only in 5 cases SD was confirmed using CHOI criteria. Median PFS and OS for SD RECIST pts were 8.3 and 22.7 months, respectively. In these 18 pts, we compared median PFS and OS of responders (CR + PR, n= 8) vs non-responders (SD + PD, n= 10) according to CHOI criteria. PFS was 11.2 vs 7.9 (p= 0.05), and OS 23.3 vs 15 months (p= 0.21).
Our analysis suggests that CHOI criteria may be helpful to define response to a biological treatment in STS. According to CHOI criteria, SD pts as defined by RECIST could be better divided in two subgroups (responders and non-responders) with a different outcome. Therefore, CHOI criteria may have an early significant predictive value for PFS in STS pts treated with biological agents.
All authors have declared no conflicts of interest.
The recent development of therapeutic approaches for Spinal Muscular Atrophy (SMA) has highlighted the need to identify clinical outcome measures for planned therapeutic clinical trials that could be ...used across spectrum of abilities. The Hammersmith Motor Function Scale (HMFS) is a functional scale already used in ongoing clinical trials. In order to assess functions related to everyday activities an add on module exploring upper limb (ULM) was developed in 2009 with the aim of better measuring weaker patients. This is also being used in an ongoing clinical trial in SMA. We report the results of a longitudinal study showing the changes on both the Hammersmith Functional Motor Scale and on the Upper Limb Module over a 12month period exploring the correlation between the two measures. Longitudinal data, including at least one assessment at baseline and one performed 12months later was obtained in 80 non ambulant SMA patients. Our results showed that the ULM widens the spectrum of functional aspects assessed, especially at the weaker end of the spectrum of non ambulant SMA. A proportion of the patients with very low scores on the HFMS were still able to achieve a few upper limb activities. Our findings suggest that the combined use of the two scales will help to improve the sensitivity of the HMFS in detecting changes over time.
In the industrialized West countries the breast cancer represents the most frequent malignant neoplasia in the women. From over 30 years we have a progressive increase of frequency of breast ...carcinoma. Mortality is substantially unchanged. The Authors, on the base of casuistry accumulated in five years of activity, trace a diagnostic-therapeutic run to the purpose to favour a line of behavior, practice and actual, for the management of breast cancer.
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