Docetaxel and prednisone with or without lenalidomide in chemotherapy-naive patients with metastatic castration-resistant prostate cancer (MAINSAIL): a randomised, double-blind, placebo-controlled phase 3 trial

Petrylak, Daniel P.; Vogelzang, Nicholas J.; Budnik, Nikolay; Wiechno, Paweł; Sternberg, Cora N.; Doner, Kevin; Bellmunt, Joaquim; Burke, John M.; Olza, María Ochoa de; Choudhury, Ananya; Gschwend, Juergen E.; Kopyltsov, Evgeny; Fléchon, Aude; As, Nicholas van; Houédé, Nadine; Barton, Debora; Fandi, Abderrahim; Jungnelius, Ulf; Li, Shaoyi; Wit, Ronald de; Fizazi, Karim

doi:10.1016/s1470-2045(15)70025-2

Cited by 139 publications

(93 citation statements)

References 27 publications

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“…When the size of the tumor in mice reached about 100-200 mm 3 , the HSA@IR780@DTX NPs (3 mg IR780/kg body weight) were injected via tail vein (n=6). Images were taken at 0, 12, 24, and 48 h after injection using the in vivo imaging system (IVIS Lumina XR III, USA).…”

Section: In Vivo Nir Fluorescence Imaging Of Hsa@ir780@dtx Nps In Vivmentioning

confidence: 99%

“…Treatments were initiated when the tumor volumes reached 100-200 mm 3 . To evaluate the thermal effect of NPs in vivo, 100 µL of HSA@IR780 and HSA@IR780@ DTX NPs (5 mg/kg, concentration of IR780) was injected into the tumor-bearing mice by vein.…”

Section: Therapeutic Efficacy Of Nps In Vivomentioning

confidence: 99%

“…[3][4][5][6] Hence, more effective therapeutic approaches need to be developed in order to improve the treatment and survival of patients with prostate cancer.…”

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confidence: 99%

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Self-assembled albumin nanoparticles for combination therapy in prostate cancer

Lian

et al. 2017

IJN

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Resistance to regular treatment strategies is a big challenge in the treatment of castration-resistant prostate cancer. Combination of photothermal and photodynamic therapy (PTT/PDT) with chemotherapy offers unique advantages over monotherapy alone. However, free drugs, such as photosensitizers and chemotherapeutic agents, lack tumor-targeted accumulation and can be easily eliminated from the body. Moreover, most of the PTT drugs are hydrophobic and their organic solvents have in vivo toxicity, thereby limiting their potential in clinical translation. Herein, simple multifunctional nanoparticles (NPs) using IR780 (a near-infrared dye) and docetaxel (DTX)-loaded nanoplatform based on human serum albumin (HSA) (HSA@IR780@DTX) was developed for targeted imaging and for PTT/PDT with chemotherapy for the treatment of castration-resistant prostate cancer treatment. In this platform, HSA is a biocompatible nanocarrier that binds to both DTX and IR780. DTX and IR780, as hydrophobic drug, can induce the self-assembly of HSA proteins. Transmission electron microscopic imaging showed that NPs formed by self-assembly are spherical with a smooth surface with a hydrodynamic diameter of 146.5±10.8 nm. The cytotoxicity of HSA@IR780@DTX NPs with or without laser irradiation in prostate cancer cells (22RV1) was determined via CCK-8 assay. The antitumor effect of HSA@IR780@DTX plus laser irradiation was better than either HSA@IR780@DTX without laser exposure or single PTT heating induced by HSA@IR780 NPs under near-infrared laser, suggesting a significant combined effect in comparison to monotherapy. Near-infrared fluorescence imaging showed that HSA@IR780@DTX NPs could preferentially accumulate in tumors. In vivo therapeutic efficacy experiment showed that xenografted prostate tumors on mice treated with HSA@IR780@DTX plus near-infrared laser irradiation were completely inhibited, whereas tumors on mice treated with chemotherapy alone (HSA@DTX and HSA@IR780@DTX without laser) or PTT/PDT alone (HSA@IR780 with laser) showed moderate growth inhibition. Overall, HSA@IR780@DTX NPs showed notable targeting and theranostic potential for the treatment of castration-resistant prostate cancer.

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Section: In Vivo Nir Fluorescence Imaging Of Hsa@ir780@dtx Nps In Vivmentioning

confidence: 99%

Section: Therapeutic Efficacy Of Nps In Vivomentioning

confidence: 99%

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Self-assembled albumin nanoparticles for combination therapy in prostate cancer

Lian

et al. 2017

IJN

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“…3 Conducted from 2009 to 2011, Mainsail, a randomized double-blind, placebo-controlled phase III clinical trial, investigated the safety and efficacy of lenalidomide (L) administered in conjunction with the current first line chemotherapy, docetaxel and prednisone (DP), in a cohort of 1059 men with metastatic castrate resistant prostate cancer (mCRPC). 4,5 The Mainsail study was closed early when investigators observed that the overall survival (OS) of patients receiving docetaxel, prednisone, and lenalidomide (DPL) was significantly worse than patients receiving docetaxel and prednisone alone.…”

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confidence: 99%

“…4 In a post hoc analysis of the Mainsail study by de Morr ee et al published in JAMA Oncology, 6 the investigators sought to answer the question: is the total number of docetaxel cycles administered to a patient with mCRPC an independent factor in overall survival?…”

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confidence: 99%

Piecing the puzzle together: Docetaxel cycles and current considerations in the treatment of metastatic castration-resistant prostate cancer

Feinman

Price

Figg

2017

Cancer Biology & Therapy

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Docetaxel is the current first line therapy for metastatic castration-resistant prostate cancer (mCRPC), but there is no standard number of docetaxel cycles given to patients. In their post hoc analysis of the Mainsail study, de Morr ee et al. show that the number of docetaxel cycles administered to a patient is a significant factor contributing to overall survival. These findings warrant further investigation into the standardization of the number of docetaxel cycles administered. KEYWORDS Docetaxel; MRPC; prostate cancerProstate cancer accounts for 21% of new cancer diagnoses in the U. S. and is the second leading cause of cancer-related deaths in men.

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