Methylphenidate in the management of asthenia in breast cancer patients treated with docetaxel: results of a pilot study.
ABSTRACT The objectives of this pilot study were to evaluate the safety and efficacy of the central nervous system stimulant methylphenidate in the management of asthenia in breast cancer patients treated with docetaxel.
Patients with early breast cancer who presented asthenia >3 on the Visual Analogue Scale (VAS) after the first cycle of docetaxel-based chemotherapy were included. Patients received two additional cycles of chemotherapy, one with methylphenidate (10 mg bid) and the other without methylphenidate. Asthenia was evaluated using VAS and the Functional Assessment of Cancer Therapy-Fatigue (FACT-F) scale. Distress was assessed using the Hospital Anxiety and Depression Scale (HADS), and quality of life using FACT-F.
Ten patients were included and evaluated for efficacy and safety. Overall, cycles with methylphenidate were better tolerated than those without methylphenidate in terms of asthenia (VAS, p = 0.004; FACT-F, p = 0.027) and quality of life (FACT-F, p = 0.047). No significant differences were observed in terms of distress (HADS, p = 0.297). Six (60%) patients continued with methylphenidate after study end. Main adverse events during study were palpitations and insomnia (30% of patients each).
This pilot study suggests that methylphenidate may reduce asthenia and improve quality of life in breast cancer patients treated with docetaxel.
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ABSTRACT: This paper reports the development and validation of a questionnaire assessing fatigue and anemia-related concerns in people with cancer. Using the 28-item Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire as a base, 20 additional questions related to the symptoms and concerns of patients with anemia were developed. Thirteen of these 20 questions dealt with fatigue, while the remaining 7 covered other concerns related to anemia. Using semi-structured interviews with 14 anemic oncology patients and 5 oncology experts, two instruments were produced: The FACT-Fatigue (FACT-F), consisting of the FACT-G plus 13 fatigue items, and the FACT-Anemia (FACT-An), consisting of the FACT-F plus 7 nonfatigue items. These measures were, in turn, tested on a second sample of 50 cancer patients with hemoglobin levels ranging from 7 to 15.9 g/dL. The 41-item FACT-F and the 48 item FACT-An scores were found to be stable (test-retest r = 0.87 for both) and internally consistent (coefficient alpha range = 0.95-0.96). The symptom-specific subscales also showed good stability (test-retest r range = 0.84-0.90), and the Fatigue subscale showed strong internal consistency (coefficient alpha range = 0.93-0.95). Internal consistency of the miscellaneous nonfatigue items was lower but acceptable (alpha range = 0.59-0.70), particularly in light of their strong relationship to patient-rated performance status and hemoglobin level. Convergent and discriminant validity testing revealed a significant positive relationship with other known measures of fatigue, a significant negative relationship with vigor, and a predicted lack of relationship with social desirability. The total scores of both scales differentiated patients by hemoglobin level (p < 0.05) and patient-rated performance status (p < 0.0001). The 13-item Fatigue subscale of the FACT-F and the 7 nonfatigue items of the FACT-An also differentiated patients by hemoglobin level (p < 0.05) and patient-rated performance status (p < or = 0.001). The FACT-F and FACT-An are useful measures of quality of life in cancer treatment, adding more focus to the problems of fatigue and anemia. The Fatigue Subscale may also stand alone as a very brief, but reliable and valid measure of fatigue.Journal of Pain and Symptom Management 03/1997; 13(2):63-74. · 2.60 Impact Factor
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ABSTRACT: The anti-cancer agent docetaxel is approved for the treatment of patients with locally advanced or metastatic breast cancer, non-small cell lung cancer (NSCLC) and for the treatment of androgen-independent prostate cancer. At the recommended dose of 60-100 mg/m2 given every 3 weeks, severe neutropenia is the dose-limiting toxicity and a major concern especially when treating patients at high-risk from myelotoxic complications. A less toxic schedule, involving weekly docetaxel administration was developed for patients with poor performance status, multiple comorbidities, poor haematological reserves or those who were heavily pre-treated, elderly or patients for whom palliation is the focus of treatment. Recent randomised trials allow a comparison of efficacy and toxicity between weekly and 3-weekly treatments. Efficacy appears to be similar for the two schedules regardless of the disease while weekly docetaxel is significantly less myelotoxic. However, this benefit comes at the cost of cumulative increases in hyperlacrimation, skin- and nail-toxicity and negatively affects quality of life. Currently, 3-weekly docetaxel remains the standard schedule for treatment, whereas the weekly schedule offers a possibility of treatment individualisation for those patients where the risk of myelosuppression is considered unacceptable.European Journal of Cancer 06/2005; 41(8):1117-26. · 5.06 Impact Factor
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ABSTRACT: Taxotere (docetaxel) at the dose of 75 mg/m(2) every 3 weeks is a standard therapy for pretreated non-small-cell lung cancer (NSCLC). The aim of this study was to evaluate the safety profile of two schedules of docetaxel administration (every 3 weeks versus weekly) in patients with pretreated NSCLC. From February 2000 to February 2001, 125 patients with locally advanced or metastatic NSCLC were randomised after failure of a previous platinum-based regimen to receive either docetaxel 75 mg/m(2) administered every 3 weeks (Dq3w) or docetaxel 40 mg/m(2) given weekly for 6 weeks followed by 2 weeks of rest (Dqw). Safety evaluations focused on grade 3-4 neutropenia, febrile neutropenia, nausea-vomiting and asthenia. Patients' characteristics were well balanced between arms. The most common National Cancer Institute Common Toxicity Criteria (NCI-CTC) grade 3-4 toxicity was neutropenia, which occurred in 48.4% of Dq3w patients versus 15.9% of Dqw patients (P=0.001). In addition, febrile neutropenia were observed in 6.5% of patients in Dq3w versus 0% in Dqw. Grade 3-4 asthenia was more frequent in Dqw. Other non-haematological toxicities were very rare. Regarding efficacy, there was a trend towards a better disease control rate in Dq3w: 32.2% versus 25.4% in Dqw. Median time to progression and survival were rather similar in both arms, respectively: 2.1 months (range 2-3.2) and 5.8 months (range 4.0-7.0) in Dq3w and 1.8 months (range 1.6-2.3) and 5.5 months (range 3.7-6.6) in Dqw. While both schedules had a favourable safety profile, a significant lower rate of severe neutropenia was observed in the weekly arm. Both regimens had similar efficacy. The weekly regimen could be considered as a good alternative for patients at risk of severe neutropenia.Annals of Oncology 02/2005; 16(1):90-6. · 7.38 Impact Factor