https://www.wileyhealthlearning.com/acs.aspx Prostate cancer survivors approach 2.8 million in number and represent 1 in 5 of all cancer survivors in the United States. While guidelines exist for timely treatment and surveillance for recurrent disease, there is limited availability of guidelines that facilitate the provision of posttreatment clinical follow‐up care to address the myriad of long‐term and late effects that survivors may face. Based on recommendations set forth by a National Cancer Survivorship Resource Center expert panel, the American Cancer Society developed clinical follow‐up care guidelines to facilitate the provision of posttreatment care by primary care clinicians. These guidelines were developed using a combined approach of evidence synthesis and expert consensus. Existing guidelines for health promotion, surveillance, and screening for second primary cancers were referenced when available. To promote comprehensive follow‐up care and optimal health and quality of life for the posttreatment survivor, the guidelines address health promotion, surveillance for prostate cancer recurrence, screening for second primary cancers, long‐term and late effects assessment and management, psychosocial issues, and care coordination among the oncology team, primary care clinicians, and nononcology specialists. A key challenge to the development of these guidelines was the limited availability of published evidence for management of prostate cancer survivors after treatment. Much of the evidence relies on studies with small sample sizes and retrospective analyses of facility‐specific and population databases. CA Cancer J Clin 2014;64:225–249. © 2014 American Cancer Society.
Purpose: Abraxane (ABI-007) is a 130-nm albumin-bound (nab) particle formulation of paclitaxel, devoid of any additional excipients. We hypothesized that this change in formulation alters the systemic disposition of paclitaxel compared with conventional solvent-based formulations (sb-paclitaxel; Taxol), and leads to improved tolerability of the drug. Patients and Methods: Patients with malignant solid tumors were randomized to receive the recommended single-agent dose of nab-paclitaxel (260 mg/m 2 as a 30-minute infusion) or sb-paclitaxel (175 mg/m 2 as a 3-hour infusion). After cycle 1, patients crossed over to the alternate treatment. Pharmacokinetic studies were carried out for the first cycle of sb-paclitaxel and the first two cycles of nab-paclitaxel. Results: Seventeen patients were treated, with 14 receiving at least one cycle each of nabpaclitaxel and sb-paclitaxel. No change in nab-paclitaxel pharmacokinetics was found between the first and second cycles (P = 0.95), suggesting limited intrasubject variability. Total drug exposure was comparable between the two formulations (P = 0.55) despite the dose difference. However, exposure to unbound paclitaxel was significantly higher after nab-paclitaxel administration, due to the increased free fraction (0.063 F 0.021versus 0.024 F 0.009; P < 0.001).Conclusion: This study shows that paclitaxel disposition is subject to considerable variability depending on the formulation used. Because systemic exposure to unbound paclitaxel is likely a driving force behind tumoral uptake, these findings explain, at least in part, previous observations that the administration of nab-paclitaxel is associated with augmented antitumor efficacy compared with solvent-based paclitaxel.nab-paclitaxel (ABI-007; Abraxane) is an albumin-bound particle formulation of paclitaxel, devoid of any solvent excipients. Paclitaxel, an antimicrotubule chemotherapeutic agent currently used alone or in combination with other anticancer drugs in the treatment of a wide range of solid tumor malignancies, is highly lipophilic and insoluble in water (1, 2). As such, it has traditionally been formulated as Taxol (sb-paclitaxel), in a mixture of Cremophor EL (polyoxyethylated castor oil) and ethanol, to allow for i.v. infusion (3). Due to the incidence of severe hypersensitivity reactions to Cremophor EL, patients are routinely pretreated with histamine blockers and steroids (4). In addition to the need for premedication, the presence of Cremophor EL has been shown to affect the pharmacokinetics of paclitaxel, due to micellar encapsulation of the drug (3). This leads to a decreased fraction of unbound drug, which limits drug distribution and clearance, and eventually results in nonlinear pharmacokinetics by decreasing the uptake of paclitaxel in RBC and tissues, thereby interfering with metabolism and biliary secretion.Conversely, nab-paclitaxel can be simply dissolved in saline for infusion. An initial phase I clinical trial has shown that this drug is tolerated up to a maximum tolerated dose o...
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