Table 1.
Identified studies reporting use of leuprolide in the treatment of advanced prostate cancer
| Study | Formulation, dose, max study duration | Cases | Mean [median] T level | % suppression [per evaluable pt] (at study end) at 50 ng/mL | % suppression [per evaluable pt] (at study end) at 20 ng/mL | Study type and PCa stage |
|---|---|---|---|---|---|---|
| Perez-Marreno37,* | 1 M Eligard, 7.5 mg, 6 M | 120 | 6.3 | 93.3 [94.1] (99.3 at 6 M) | 95.8 [97.5] at 42 D (95.8 at 6 M) | Prospective; PCa C1 or greater, T3 or greater |
| Heyns36 | 1 M Eligard, 7.5 mg, 9 M | 140 | NR | 99.3 | (97.3 at 2–9 M) | Prospective cohort (RCT arm); advanced PCa |
| Fujii44 | 1 M Enantone, 3.75 mg, up to 10 Y | 40 | 11.0 | 95.0 | Retrospective; metastatic and non-metastatic | |
| Marberger38 | 1 M Lutrate, 3.75 mg, 24 W | 160 | 4.12 | 95.0 [96.8] (95.0 at 24 W) | 71.3 [73.1] (88.1 at 24 W) | Prospective; all stages |
| You16 | 1 M Lorelin, 3.75 mg, 12 W | 104 | NR | 83.7 [93.8] (82.7 at 3 M) | Prospective; all stages | |
| Chu24,* | 3 M Eligard, 22.5 mg, 6 M | 117 | 10.1 | 98.3 [99.1] (94.9 at 6 M) | 83.8 [84.5] (88.9 at 6 M) | Prospective; PCa>A2>T1 |
| Oefelein39 | 3 M Eligard, 22.5 mg, 18 M (single dose) | 13 | [10] | 92 | Prospective; localized PCa | |
| Oefelein40 | 3 M Eligard, 22.5 mg, 12+ M, 1–2 doses | 32 | [20] | 97 | Prospective; T3N ± M± or greater | |
| Oefelein and Cornum41 | 3 M Eligard, 22.5 mg, 15 M (single dose) | 38 | NR | 94.7 | 86.8 | Prospective; advanced PCa |
| Yri45 | 3 M Enantone, 11.25 mg, 12 W | 40 | 17.3 | Retrospective series; locally advanced | ||
| Fujii44 | 3 M Enantone, 11.25 mg, up to 10 Y | 68 | 12.0 | 98.5 | Retrospective series; metastatic and non-metastatic | |
| Crawford42,* | 6 M Eligard, 45 mg, 12 M | 103 | 12.3 | 97.3 [99.1] (91.9 at 12 M) | 82.9 [84.4] (82.0 at 12 M) | Prospective; PCa>T1, A2–A4 |
| Spitz43 | 6 M Lupron, 45 mg, 48 W | 151 | 15 | 93.4 [93.6] (93.4 at 48 W) | Prospective; stage 2–4, also PSA failure |
Notes:
*
Included in the analysis. Registered trademarks: Eligard®, Sanofi S.A./Tolmar Therapeutics Inc (Fort Collins, CO, USA); Enantone®, Takeda (Osaka, Japan); Lutrate®, GP Pharm S.A. (Barcelona, Spain); Lorelin®, Dongkook (Seoul, South Korea); Lupron®, Abbott Laboratories (north Chicago, IL, USA).
Abbreviations: PCa, prostate cancer; D, days; W, weeks; M, months; Y, years; NR, not reported; PSA, prostate-specific antigen.