Measuring the side effects of taxane therapy in oncology

Abstract

BACKGROUND Cancer chemotherapy with some of the taxane class of agents can be associated with significant neurotoxicity, arthralgias, myalgias, and skin changes that may offset the therapeutic benefits of taxane use. METHODS The authors developed and tested a set of questions to assess these important side effects of taxane therapy from the patient's perspective. The current study evaluated the taxane subscale of the Functional Assessment of Chronic Illness Therapy (FACIT) measurement system. Reliability, validity, and responsiveness to expected change were evaluated in the context of an ongoing clinical trial comparing four cycles of carboplatin plus paclitaxel with a strategy of carboplatin plus paclitaxel until disease progression in patients with advanced nonsmall cell lung carcinoma (NSCLC). RESULTS The 16‐item Taxane subscale score and the 11‐item peripheral neuropathy subset both demonstrated excellent internal consistency and concurrent validity, and the scores worsened as one would predict during a 12‐week treatment course of taxane therapy. Results of the psychometric analyses supported the use of this subscale for measuring the unwanted adverse consequences of effective cancer therapies. Measuring the patient perception of treatment side effects also allowed a preliminary exploration of the relative quality of life (QOL) impact of symptom relief and treatment toxicity. The results indicated that toxicity and symptom improvement may make relatively equivalent contributions to total QOL as measured by the summary score from a multidimensional QOL instrument, the Functional Assessment of Cancer Therapy–General. However, symptom status and improvement appear to play a stronger role than taxane toxicity in patients' global rating of their QOL. CONCLUSIONS Future research might examine this question of competing benefits as a potential aid to decision‐making regarding the administration of toxic therapies in the setting of advanced disease. Cancer 2003;98:822–31. © 2003 American Cancer Society.

Prospective assessment of chemotherapy-induced peripheral neuropathy due to weekly paclitaxel in patients with advanced or metastatic breast cancer (CSP-HOR 02 study)

“…The impact of CIPN on patients' HR-QOL was assessed using the Functional Assessment of Cancer Therapy (FACT)-Taxane including FACT-General (G), neurotoxicity component (Ntx), and taxane component [6]. The PNQ and HR-QOL questionnaires were distributed to the patients by clinical research coordinators (CRCs) or physicians and filled out by the patients at the same time point as the assessment of CIPN by a physician.…”

Subjective and Objective Assessment of Edema during Adjuvant Chemotherapy for Breast Cancer Using Taxane-Containing Regimens in a Randomized Controlled Trial: The National Surgical Adjuvant Study of Breast Cancer 02

“…We asked the participants to respond to the Functional Assessment of Cancer Therapy-breast (FACT-B) [20,21] and -taxane (FACT-T) subscale [13,22] questionnaires at baseline, on day 1 of cycles 3, 5 and 7, and 7 and 12 months after enrollment. QOL was assessed either at the 7-month time point or 1–2 months after completion of the protocol-specified 8th cycle of treatment to collect data when the patients had somewhat recovered from the invasive treatment.…”

Prevention and Management of Chemotherapy-Induced Polyneuropathy

“…In order to address symptomatic differences between chemotherapeutic agents (e.g., cisplatin and taxanes), various chemotherapy-specific scales have also been developed [11]. FACT-Taxane consists of both FACT-General and an added taxane subscale.…”