Real-world Data of Paclitaxel and Cetuximab in Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck.

BACKGROUND/AIM: Prior immune-checkpoint inhibitors, weekly paclitaxel-cetuximab was one of the few options for platinum-ineligible patients with recurrent/ metastatic squamous cell carcinoma of the head and neck (R/M-SCCHN). This real-world study analyzed the long-term outcomes of this regimen. PATIENTS AND METHODS: A multicenter, retrospective, observational, cross-sectional, chart review study was realized in nine hospitals of the Galician Group of Head and Neck Cancer. Eligible population was adult platinum-ineligible patients with R/M SCCHN (unfit to, or after progressing following EXTREME or other platinum-based regimens) that received weekly paclitaxel plus cetuximab regimen as first- or second-line (1L or 2L) between January 2009 and December 2014. The efficacy was evaluated (1L-2L) in regards to overall survival (OS) and progression-free survival (PFS), and safety was assessed as the incidence of adverse events (AEs). RESULTS: Seventy-five R/M-SCCHN patients received the scheme (1L, n=50; 2L: n=25). The mean age of the patients was 59 years (1L, 59.5 years; 2L, 59.2 years), 90% were male (1L, 96%; 2L, 79%), 55% were smokers (1L, 60.4%; 2L, 45.8%), and 61% presented ECOG performance status (PS) 1 (1L, 54%; 2L, 62.5%). Median OS [interquartile range (IQR)] was 8.85 (4.22-40.96) months. Median PFS (IQR) was 8.5 (3.93-12.55) (1L) and 8.8 (5.62-16.91) (2L) months. Disease control rate was 60% (1L) and 85% (2L). Weekly paclitaxel-cetuximab was well tolerated in 1L/2L (cutaneous-toxicity, mucositis, neuropathy; mainly Grade 1-2). No grade 4 AEs were notified in 2L. CONCLUSION: Weekly paclitaxel-cetuximab is an active and well tolerated therapeutical option in platinum-ineligible or after platinum regimens in R/M-SCCHN patients.

Is there a correlation between HER2 gene amplification level and response to neoadjuvant treatment with trastuzumab and chemotherapy in HER2-positive breast cancer?

There are contradictory data regarding the correlation between HER2 amplification level determined by in situ hybridization and evolution after treatment with anti-HER2 therapies. The aim of this study was to correlate quantitative results of FISH (ratio HER2/CEP17 and number of HER2 signals/nucleus) with pathological response achieved after neoadjuvant treatment with trastuzumab and chemotherapy. For this purpose, we analysed 100 consecutive HER2-positive cases of breast carcinoma treated with neoadjuvant therapy. HER2 amplification determined by FISH was found in 92 of the 100 cases studied. pCR was obtained in 58% of the patients whose tumours presented amplification. In contrast, no pCR was obtained in the 8 patients with non-amplified tumours. A significant direct correlation between HER2 high amplification (HER2/CEP17 ratio > 5 or HER2 signals/nucleus > 10) and pCR was found. In conclusion, HER2 amplification levels are clinically relevant because they provide oncologists with valuable information on the possibilities of achieving pCR after neoadjuvant treatment.

Pazopanib: Evidence review and clinical practice in the management of advanced renal cell carcinoma.

BACKGROUND: Pazopanib is indicated in the first-line treatment of metastatic renal cell cancer (mRCC). The aim of this study was to review the efficacy, safety, and pharmacokinetics of pazopanib and see how these aspects are linked to clinical practice. METHODS: A non-exhaustive systematic review was conducted according to the three topics. No publication restrictions were imposed and the selected languages were Spanish and English. After that, a summary of the main results and findings of the review was presented and discussed during three meetings (one for each topic) with 13 medical oncologists that usually treat mRCC. At these meetings, a questionnaire on the first-line use of pazopanib in clinical practice was also drawn up. After the meetings, the questionnaire was completed by 60 specialist medical oncologists in renal cancer. RESULTS: The efficacy and safety of pazopanib have been demonstrated in several clinical trials, and subsequently confirmed in studies in real-world clinical practice. In addition to its clinical benefit and good safety profile, quality of life results for pazopanib, which compare favorably to sunitinib, make it a good option in the first-line treatment of patients. Special populations have been included in studies conducted with pazopanib, and it is safe for use in elderly patients, poor functional status, kidney failure, and mild or moderate hepatic impairment, and in patients with concomitant cardiovascular disease. The results of the questionnaire have shown that pazopanib is perceived as an effective drug, in which quality of life (QoL) outcomes are valued above all. CONCLUSIONS: This paper offers a comprehensive and critical summary of efficacy, tolerability, and pharmacokinetics of pazopanib in the treatment of mRCC. Pazopanib is an effective treatment with an acceptable safety profile. Its QoL and tolerability results offer certain advantages when compared with other therapeutic alternatives, and its use appears to be safe in different patient profiles.