Table 1.
Efficacy of Rapamycin Analogs in Selected Clinical Trials
| Study Treatment | Phase | Disease | No. of Patients | Objective Response (PR or CR, %) |
|---|---|---|---|---|
| Hudes, 200743 | III | RCC | ||
| Temsirolimus (25 mg IV qwk) | 209* | 8.6 | ||
| Interferon | 207* | 4.8 | ||
| Temsirolimus + interferon | 210* | 8.1 | ||
| Motzer, 200844 | III | RCC | ||
| Everolimus (10 mg po qd) | 272* | 1 | ||
| Placebo | 138* | 0 | ||
| Hess, 200848 | III | Mantle-cell lymphoma | ||
| Temsirolimus (175 mg × 3 doses, followed by 75 mg qwk) | 54* | 22 | ||
| Temsirolimus (mg × 3 doses, followed by 25 mg qwk) | 54* | 6 | ||
| Investigator's choice | 54* | 2 | ||
| Galanis, 2005105 | II | GBM | ||
| Temsirolimus (250 mg IV qwk) | 64† | 0‡ | ||
| Atkins, 200441 | II | RCC | ||
| Temsirolimus (250 mg IV qwk) | 37* | 8.1 | ||
| Temsirolimus (75 mg IV qwk) | 38* | 7.9 | ||
| Temsirolimus (25 mg IV qwk) | 36* | 5.6 | ||
| Witzig, 200546 | II | Mantle-cell lymphoma | ||
| Temsirolimus (250 mg IV qwk) | 34† | 38 | ||
| Chan, 200542 | II | Breast cancer | ||
| Temsirolimus (250 mg IV qwk) | 54* | 7.4 | ||
| Temsirolimus (75 mg IV qwk) | 55* | 10.9 | ||
| Margolin, 2005106 | II | Melanoma | ||
| Temsirolimus (250 mg IV qwk) | 33† | 3 | ||
| Duran, 200667 | II | Neuroendocrine | ||
| Temsirolimus (25 mg IV qwk) | 36* | 5.6 | ||
| Chawla, 200650 | II | Sarcoma | ||
| Deforolimus (12.5 mg IV qd × 5, every 2 wks) | 193† | 3¶ | ||
| Colombo, 200751 | II | Endometrial cancer | ||
| Deforolimus (12.5 mg IV qd × 5, every 2 wks) | 27† | 7∥ | ||
| Pandya, 200786 | II | SCLC | ||
| Temsirolimus (250 mg IV qwk) | 41† | 0 | ||
| Temsirolimus (25 mg IV qwk) | 44† | 2.3 | ||
| Smith, 200847 | II | Lymphoma (non–mantle-cell, non-Hodgkins') | ||
| Temsirolimus (25 mg IV qwk) | 74* | 35 | ||
| Rizzieri, 2008107 | II | Hematologic malignancies | ||
| Deforolimus (12.5 mg IV qd × 5, every 2 wks) | 52† | 10 | ||
| Slomovitz, 200862 | II | Endometrial | ||
| Everolimus (10 mg po qd) | 25† | 0¶ | ||
| Ansell, 200845 | II | Mantle-cell lymphoma | ||
| Temsirolimus (25 mg IV qwk) | 27† | 41 |
Abbreviations: PR, partial response; CR, complete response; RCC, renal cell carcinoma; IV, intravenously; po, by mouth; qd, every day; qwk, every week; GBM, glioblastoma multiforme; SCLC, small-cell lung cancer.
*
No. of intent-to-treat patients.
†
No. of assessable patients.
‡
Thirty-six percent of patients had evidence of improvement on neuroimaging.
§
Stable disease in 25% of patients.
∥
Stable disease in 26% of patients.
¶
Stable disease in 44% of patients.