Prospective observational study on Pazopanib in patients treated for advanced or metastatic renal cell carcinoma in countries in Asia Pacific, North Africa, and Middle East regions: PARACHUTE study.

BACKGROUND: Clinical effectiveness and safety data of pazopanib in patients with advanced or mRCC in real-world setting from Asia Pacific, North Africa, and Middle East countries are lacking. METHODS: PARACHUTE is a phase IV, prospective, non-interventional, observational study. Primary endpoint was the proportion of patients remaining progression free at 12 months. Secondary endpoints were ORR, PFS, safety and tolerability, and relative dose intensity (RDI). RESULTS: Overall, 190 patients with a median age of 61 years (range: 22.0-96.0) were included. Most patients were Asian (70%), clear-cell type RCC was the most common (81%), with a favourable (9%), intermediate (47%), poor (10%), and unknown (34%) MSKCC risk score. At the end of the observational period, 78 patients completed the observational period and 112 discontinued the study; 60% of patients had the starting dose at 800 mg. Median RDI was 82%, with 52% of patients receiving < 85%. Of the 145 evaluable patients, 56 (39%) remained progression free at 12 months, and the median PFS was 10 months (95% CI: 8.48-11.83). 19% of patients (21/109) were long-term responders (on pazopanib for ≥18 months). The best response per RECIST 1.1 was CR/PR in 24%, stable disease in 44%, and PD in 31%. Most frequent (> 10%) TEAEs related to pazopanib included diarrhoea (30%), palmar-plantar erythrodysesthesia syndrome (15%), and hypertension (14%). CONCLUSIONS: Results of the PARACHUTE study support the use of pazopanib in patients with advanced or mRCC who are naive to VEGF-TKI therapy. The safety profile is consistent with that previously reported by pivotal and real-world evidence studies.

Effects of herbal medicine for xerostomia in head and neck cancer patients: an observational study in a tertiary cancer hospital.

PURPOSE: More than 80% head and neck cancer patients endured radiotherapy-induced xerostomia which impacts their quality of life (QoL). This observational study evaluated the effect of herbal treatment on head and neck cancer patients' xerostomia and QoL. METHODS: Head and neck cancer patients were recruited from July 2016 till March 2017 at National Cancer Institute, Ministry of Health, Malaysia. All study participants continued their standard oncology surveillance. Treatment group participants additionally received Chinese herbal treatment. The assessments included unstimulated salivary flow rate (USFR), stimulated salivary flow rate (SSFR), and QoL questionnaire. RESULTS: Of 42 recruited participants, 28 were in the treatment group and 14 were in the control group. Participants were mainly Chinese (71.4%), stage III cancer (40.5%), and had nasopharynx cancer (76.2%). The commonly used single herbs were Wu Mei, San Qi, and Tian Hua Fen. Sha Shen Mai Dong Tang, Liu Wei Di Huang Wan, and Gan Lu Yin were the frequently prescribed herbal formulas. The baseline characteristics, USFR, SSFR, and QoL between control and treatment groups were comparable (p > 0.05). USFR between control and treatment groups were similar throughout the 6-month study period. SSFR for the treatment group significantly improved from 0.15 ± 0.28 ml/min (baseline) to 0.32 ± 0.22 ml/min (p = 0.04; at the 3rd month) and subsequently achieved 0.46 ± 0.23 ml/min (p = 0.001; at the 6th month). The treatment group had better QoL in terms of speech (p = 0.005), eating (p = 0.02), and head and neck pain (p = 0.04) at the 6th month. CONCLUSION: Herbal treatment may improve xerostomia and QoL in post-radiotherapy head and cancer patients.

Treatment decision-making among breast cancer patients in Malaysia.

PURPOSE: This study investigated breast cancer patients' involvement level in the treatment decision-making process and the concordance between patients' and physician's perspectives in decision-making. PARTICIPANTS AND METHODS: A cross-sectional study was conducted involving physicians and newly diagnosed breast cancer patients from three public/teaching hospitals in Malaysia. The Control Preference Scale (CPS) was administered to patients and physicians, and the Krantz Health Opinion Survey (KHOS) was completed by the patients alone. Binary logistic regression was used to determine the association between sociodemographic characteristics, the patients' involvement in treatment decision-making, and patients' preference for behavioral involvement and information related to their disease. RESULTS: The majority of patients preferred to share decision-making with their physicians (47.5%), while the second largest group preferred being passive (42.6%) and a small number preferred being active (9.8%). However, the physicians perceived that the majority of patients preferred active decision-making (56.9%), followed by those who desired shared decision-making (32.8%), and those who preferred passive decision-making (10.3%). The overall concordance was 26.5% (54 of 204 patient-physician dyads). The median of preference for information score and behavioral involvement score was 4 (interquartile range [IQR] =3-5) and 2 (IQR =2-3), respectively. In univariate analysis, the ethnicity and educational qualification of patients were significantly associated with the patients' preferred role in the process of treatment decision-making and the patients' preference for information seeking (p>0.05). However, only educational qualification (p=0.004) was significantly associated with patients' preference for information seeking in multivariate analysis. CONCLUSION: Physicians failed to understand patients' perspectives and preferences in treatment decision-making. The concordance between physicians' perception and patients' perception was quite low as the physicians perceived that more than half of the patients were active in treatment decision-making. In actuality, more than half of patients perceived that they shared decision-making with their physicians.

Treatment outcome for head and neck squamous cell carcinoma in a developing country: University Malaya Medical Centre, Malaysia from 2003-2010.

BACKGROUND: Head and neck cancer (HNC) is the eighth most common cancer as estimated from worldwide data. The incidence of HNC in Peninsular Malaysia was reported as 8.5 per 100,000 population. This study was aimed to determine the treatment outcomes for HNC patients treated in the Oncology Unit of University Malaya Medical Centre (UMMC). MATERIALS AND METHODS: All newly diagnosed patients with squamous cell carcinoma of head and neck (HNSCC) referred for treatment to the Oncology Unit at UMMC from 2003-2010 were retrospectively analyzed. Treatment outcomes were 5-year overall survival (OS), cause specific survival (CSS), loco-regional control (LRC) and radiotherapy (RT) related side effects. Kaplan-Meier and log rank analyses were used to determine survival outcomes, stratified according to American Joint Committee on Cancer (AJCC) stage. RESULTS: A total of 130 cases were analysed. Most cases (81.5%) were at late stage (AJCC III-IVB) at presentation. The 5-year OS for the whole study population was 34.4% with a median follow up of 24 months. The 5-year OS according to AJCC stage was 100%, 48.2%, 41.4% and 22.0% for stage I, II, III and IVA-B, respectively. The 5-year overall CSS and LCR were 45.4% and 55.4%, respectively. Late effects of RT were documented in 41.4% of patients. The most common late effect was xerostomia. CONCLUSIONS: The treatment outcome of HNSCC at our centre is lagging behind those of developed nations. Efforts to increase the number of patients presenting in earlier stages, increase in the use of combined modality treatment, especially concurrent chemoradiotherapy and implementation of intensity modulated radiotherapy, may lead to better outcomes for our HNC patients.