Docetaxel, oxaliplatin, and capecitabine combination chemotherapy for metastatic gastric cancer.

BACKGROUND: The incorporation of docetaxel into the cisplatin and fluorouracil backbone has been demonstrated to be an active combination in metastatic gastric cancer. Nevertheless, this regimen is burdened by nonnegligible toxicity. We hypothesized that replacing cisplatin and fluorouracil with oxaliplatin and capecitabine should be an active and safe option for metastatic gastric cancer patients. METHODS: In this phase II study, we tested the activity of docetaxel in combination with oxaliplatin and capecitabine (DOC) as a first-line treatment. DOC was administered as follows: docetaxel (60 mg/m(2)) and oxaliplatin (100 mg/m(2)) on day 1, and capecitabine (500 mg/m(2)) was administered orally twice daily given continuously, with cycles repeated every 3 weeks. The primary endpoint was the overall response rate. RESULTS: Forty-eight patients entered the study. All patients had metastatic disease (stage IV). None of the patients had previously received chemotherapy for advanced disease. Performance status was 0, 1, and 2 in 25, 58, and 17 % of patients, respectively; 13 patients (27 %) had adenocarcinoma of the gastroesophageal junction, and 29 patients (60.5 %) had two or more metastatic sites. The overall response rate was 52.1 %. Progression-free survival and overall survival were 6.9 and 12.6 months, respectively. The treatment was well tolerated with no treatment-related deaths. The most common grade 3-4 toxicity was neutropenia (41 %). CONCLUSIONS: DOC is an effective and tolerated first-line treatment, and the lower dose of docetaxel and oxaliplatin used in this study compared with other similar regimens does not seem to hamper the antitumor activity.

The Art of Counseling in the Treatment of Head and Neck Cancer: Exploratory Investigation among Perceptions of Health Professionals in Southern Italy.

(1) Background: Recurrent and/or metastatic patients with head and neck squamous cell carcinoma show a poor prognosis, which has not changed significantly in 30 years. Preserving quality of life is a primary goal for this subset of patients; (2) Methods: A group of 19 physicians working in South Italy and daily involved in head and neck cancer care took an anonymous online survey aimed at revealing the level of knowledge and the application of communication techniques in daily patient care; (3) Results: Several specialists, 18 out 19 (95%), considered that patient participation in therapeutic choices is mandatory. The main obstacles to complete and reciprocate communication still consist of lack of time and staff, but also in the need for greater organization, which goes beyond the multidisciplinary strategy already used; (4) Conclusions: A greater impulse to training and updating on issues related to counseling can improve communication between the different clinicians involved in the treatment plan.

Quality of Life in Patients With Severe Skin Reactions in Course of First-Generation Epidermal Growth Factor Receptor Inhibitors Monoclonal Antibodies (Our Experience With Cetuximab).

BACKGROUND: Metastatic colorectal cancer (mCRC) with wild type expression of RAS and RAF genes can be treated with anti-epidermal growth factor receptor (EGFR) monoclonal antibodies, such as cetuximab, in combination with chemotherapy. Skin toxicity represents the most serious and frequent side effect in these patients. Skin manifestations occur in approximately 80% of patients. In this study, we investigated the consequences on body image and quality of life (QoL) of patients with severe skin toxicity. METHODS: One hundred patients were enrolled with mCRC. All patients signed informed consent and completed questionnaires to assess QoL and body discomfort. Toxicity was assessed on Common Terminology Criteria for Adverse Events (CTCAEs). RESULTS: The greatest impact on QoL was represented by difficulties in managing skin rash-related side effects. Data showed a significant impact in psychological sphere and social relationships. CONCLUSIONS: Skin side effects, particularly rash, influence QoL and social relationships, compromising therapeutic compliance.

Multicenter phase II trial of first-line docetaxel/gemcitabine in advanced breast cancer pretreated with adjuvant anthracyclines.

UNLABELLED: The aim of this study was to evaluate activity and tolerability of docetaxel-gemcitabine combination as first-line treatment in patients with metastatic breast cancer previously treated with adjuvant anthracyclines. PATIENTS AND METHODS: Sixty-eight women received gemcitabine 1,000 mg/m(2) as 30-minute infusion on days 1 and 8, and docetaxel 80 mg/m(2) as 1-hour infusion on day 8, with cycles repeated every 3 weeks. RESULTS: Objective responses were observed in 32 out of 68 evaluable patients (45%; 95% confidence interval, 35.2-58.8%). Responses were 44%, 42%, 49% in soft tissue, bone and visceral lesions, respectively, 50% /52% in HER2-positive/-negative tumors, and 50% in both ER- positive/-negative tumors. Median time to progression and overall survival were 6 and 16 months, respectively. Treatment was usually well tolerated, with grade 3-4 neutropenia in 32% - 7% of the patients, and neutropenic fever, grade 3 vomiting, mucositis and peripheral neurotoxicity in 3% of the patients. CONCLUSION: Gemcitabine-docetaxel combination is effective and well tolerated as first-line treatment in advanced breast cancer previously treated with adjuvant anthracyclines.

Identification of subgroups of early breast cancer patients at high risk of nonadherence to adjuvant hormone therapy: results of an Italian survey.

BACKGROUND: Adherence to adjuvant endocrine therapy (HT) is suboptimal among breast cancer patients. A high rate of nonadherence might explain differences in survival between clinical trial and clinical practice. Tailored interventions aimed at improving adherence can only be implemented if subgroups of patients at higher risk of poor adherence are identified. Because no data are available for Italy, we undertook a large survey on adherence among women taking adjuvant HT for breast cancer. PATIENTS AND METHODS: Patients were recruited from 10 cancer clinics in central Italy. All patients taking HT for at least 1 year were invited, during one of their follow-up visit, to fill a confidential questionnaire. The association of sociodemographic and clinical characteristics of participants with adherence was assessed using logistic regression. The RECPAM method was used to evaluate interactions among variables and to identify subgroups of patients at different risk of nonadherence. RESULTS: A total of 939 patients joined the study and 18.6% of them were classified as nonadherers. Among possible predictors, only age, working status, and switching from tamoxifen to an aromatase inhibitor were predictive of nonadherence in multivariate analysis. RECPAM analysis led to the identification of 4 classes of patients with a different likelihood of nonadherence to therapy, the lowest being observed in retired women with a low level of education, the highest in the group of unmarried, employed women, or housewives. CONCLUSION: The identification of these subgroups of "real life" patients with a high prevalence of nonadherers might be functional in designing intervention studies aimed at improving adherence.

Single-dose palonosetron and dose-reduced regimen of dexamethasone in preventing nausea and vomiting by anthracycline-including chemotherapy in patients with early breast cancer.

AIM: To evaluate the efficacy of reduction of dexamethasone with a single-dose of palonosetron in preventing acute and delayed nausea and vomiting in patients receiving highly emetogenic chemotherapy (HEC) for early breast cancer. PATIENTS AND METHODS: Chemotherapy-naive patients with breast cancer were given HEC in an adjuvant or neoadjuvant setting. Palonosetron and dexamethasone 4 mg i.v. were given on day 1 and another two administrations of dexamethasone 4 mg i.m. were given on days 2 and 3. The end-point was complete response (CR) and complete control (CC) during the acute and delayed phases. RESULTS: Twenty-six patients were observed. Complete response was achieved in 19 out of 26 patients (72.4%); the same result was shown in 72.4% out of 76 courses given. CONCLUSION: This alternative schedule suggests efficacy for the control of acute and delayed emesis in moderately emetogenic chemotherapy. Further investigations are required to confirm these results.

Phase II study of epirubicin, oxaliplatin and docetaxel combination in metastatic gastric or gastroesophageal junction adenocarcinoma.

BACKGROUND: This phase II study was designed to evaluate the activity and safety of a combination of epirubicin, oxaliplatin and docetaxel in metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. METHODS: Forty patients with measurable distant metastases received epirubicin 50 mg/m2, docetaxel 60 mg/m2 followed by oxaliplatin 100 mg/m2 on day 1 of each 21-day cycle. Primary end point was response rates (RR). RESULTS: All patients were evaluable. The overall RR was 47.5% (95% confidence interval (CI) 32-63). The disease control was 80%. Median time for response was 6 weeks. Median time to progression was 6.3 months (95% CI 5.4-7.2) and the median overall survival time was 12.1 months (95% CI 10.7-13.5). Grade 3/4 neutropenia occurred in 50% of patients with two episodes of febrile neutropenia (5%). Other non-hematological grade 3 toxicities included sensory neuropathy in two patiens (5%), vomiting and mucositis in two patients (5%) and diarrhea in one patient (2.5%). CONCLUSION: The combination of epirubicin, oxaliplatin and docetaxel was found to be effective and well tolerated in patiens with metastatic gastric or GEJ adenocarcinoma and maybe an appropriate regimen to be used in the neoadjuvant setting and with molecularly targeted agents.