Background
Methods
Results
Results of Literature Search
Case Reports
Case Series
Author [reference], Year | Patient Characteristics | Treatment | Responses |
---|---|---|---|
Postlethwait et al [68], 1951 | 4 gastric, 1 rectal, 1 gallbladder, 1 esophageal, all advanced stage | 300 mg IM of cortisone on day 1, 200 mg IM on day 2 then 100 mg IM daily for 21 days; one patient received 150 mg instead of 100 mg | no objective improvement |
de Camp [69], 1961 | 255 bronchogenic carcinoma, 19 primary lung tumors of other origins (sarcoma, adenomatosis etc.), 6 alveolar cell carcinoma of lung, 14 with cancer metastatic to lung, 26 pleural carcinoma, 2 pericardial carcinoma | patients received 30–40 mg of prednisone/prednisolone per day, which was tapered to 10–15 mg per day (occasionally to 5 mg per day) or 4 mg of dexamethasone per day tapered to 1–1.5 mg per day | no effect, either positive or negative |
Plengvanit and Viranuvatti [70], 1964 | 7 primary carcinoma of the liver | 40–60 mg of daily prednisone for 2 weeks to 10 months | little value as based on effect on pain and liver size (by physical examination) |
Bruera et al [67], 1985 | 8 colon, 7 breast, 4 lung, 4 soft tissue sarcoma, 2 kidney, 2 prostate, 1 head and neck, 1 melanoma, 1 pancreas, 1 ovarian | methyprednisolone 16 mg po twice daily for 25 out of 34 days | no tumor regression |
Glucocorticoid Activity | |
---|---|
Cortisol (Hydrocortisone) | 1 |
Cortisone | 0.8 |
Prednisone | 4 |
Prednisolone | 4 |
Methylprednisolone | 5 |
Dexamethasone | 30 |
Phase l and Phase ll (Nonrandomized) Trials
Author [reference], Year | Patient Characteristics | Treatment | Responses |
---|---|---|---|
Mass [63], 1964 | 32 lung cancer (17 epidermoid, 7 adenocarcinoma, 8 undifferentiated) 26 GI, 18 GU, 7 melanoma, 2 breast | 25–100 mg flurometholone po per day for 7 weeks followed by taper | None |
Moertel et al [64], 1964 | 18 colon, 13 gastric, 9 pancreatic, 5 carcinoid, 12 primary unknown (presumed GI), 6 miscellaneous GI, 1 renal cell | 25 mg fluorometholone po every 12 hr for at least 2 months | 4 PR (1 colon, 1 gastric, 2 primary unknown) |
Johnson et al [65], 1966 | 44 melanoma, 9 lung carcinoma, 5 ovary, 4 uterus, 4 prostate, 4 kidney, 4 breast, 7 miscellaneous | 200–600 mg of NSC-17256 per day po for 8 weeks | melanoma (3 CR, 2 PR) |
Ramirez et al [66], 1971 | 24 head and neck, 1 gastric, 36 colorectal, 2 pancreas, 13 lung, 70 breast, 36 cervix, 12 uterus, 9 ovary, 9 prostate, 27 kidney, 2 bladder, 111 melanoma, 1 thyroid, 6 liver, 29 sarcoma, 11 primary unknown, 1 lymphoma, 7 miscellaneous | 200–600 mg of NSC-17256 per day po for 6 weeks; average dose 300 mg per day | Head and neck (1 PR), breast (1 CR, 8 PR), uterus/cervix (2 PR), ovary (1 PR), prostate (1 CR, 3 PR), melanoma (6 PR), Hodgkin (1 PR) |
Randomized Controlled Trials of Glucocorticoids in the Endocrine Therapy of Advanced Breast Cancer
Author [reference], Year | Patient Characteristics | Treatment Arms and Patient Numbers (Randomized/Evaluable) | Quality Score | Outcome |
---|---|---|---|---|
Dao et al [19], 1961 | postmenopausal, previous androgens or estrogens for advanced disease | bilateral adrenalectomy + hormone replacement (19/18) vs. cortisone acetate (at least 3 months; 300 mg on first day tapered to 50 mg daily) (20/19) | 1 | 8 vs. 0 remissions |
Colsky et al [5], 1963 | Postmenopausal | 100 mg of 9α-bromo-11β-ketoprogesterone po every 8 hrs for at least 60 days (32/23) vs. same except 13.2 mg of prednisolone (23/18) | 4 | 0 vs. 1 remission |
Talley et al [22], 1964 | postmenopausal, no previous endocrine therapy | 10 mg of fluoxymesterone (an androgen) po twice daily (23/21) vs. 25 mg of oxylone acetate po twice daily (23/22) | 2 | 3 vs. 6 remissions (ns) |
Talley et al [22], 1964 | postmenopausal, previous androgens or estrogens | 25 mg of oxylone acetate po twice daily (14/NR) vs. 12 mg of methylprednisolone twice daily (13/NR) | 4 | 3 vs. 3 remissions |
Gaertner et al [18], 1968 | Postmenopausal | dromostanolone propionate (an androgen) 100 mg IM 3 times weekly (22/NR) vs. fluorometholone 25 mg po daily (22/NR) vs both together (24/NR) | 3 | 9 vs. 2 vs. 5 responses |
Goldenberg [15], 1969 | postmenopausal, no previous hormonal therapy | Testololactone (an androgen) 75 mg twice daily po (103/100) vs. MPA 50 mg twice daily po (108/104) vs. oxylone acetate 25 mg twice daily po (108/107) | 2 | response rates of 4.9% vs. 9.3% vs. 19.4%; p = 0.052 for MPA and oxylone being equal |
Jakobsen et al [38], 1986 | 95% previous antiestrogen therapy, 83% postmenopausal | prednisone 10 mg po three times daily (52/43) vs. MPA 500 mg po daily (48/38) vs. MPA 100 mg IM daily except Sat/Sun for 3 weeks then 500 mg IM weekly(50/40); continued until PD | 1 | response rates of 4.6% vs. 7.9% vs. 12.5% (ns), median time to progression of 3 vs. 2.5 vs. 4 months (p = 0.09), median survival of 6 vs. 8.5 vs. 10 months (p = 0.30) |
Wander et al [56], 1987 | 81% postmenopausal, 40.5% ER and/or PgR +ve, 26.7% ER/PgR -ve, 32.8% ER/PgR unknown | aminoglutethimide 1000 mg po daily + cortisone acetate 50 mg po daily (65/62) vs. aminoglutethimide 1000 mg po daily + MPA 1000 mg po daily (73/69) | 1 | response rates (CR/PR) of 6.5%/25.8% vs. 7.3%/24.6% |
Kristensen et al, [47] 1992 | Hypercalcemia due to breast cancer | standardized isotonic saline + IV furosemide (15/15) vs. same + prednisolone 25 mg po three times daily for 8 days (15/15) | 3 | median survival of 40 days vs. 84 days (p = 0.46) |
Mercer et al, [55] 1993 | postmenopausal; PD on tamoxifen (adjuvant or advanced setting) | aminoglutethimide 125 mg twice daily (28/27) vs. hydrocortisone 20 mg twice daily (33/29) | 2 | response rates in 11% vs. 21% (p > 0.1), time to treatment failure similar (p = 0.743), overall survival similar (p = 0.240) |
Stewart et al [24], 1982 | Only previous systemic therapy allowed was adjuvant chemotherapy, 98 ER +ve, 28 ER -ve, 54 ER unknown | Premenopausal: ovarian irradiation (19) vs. same + prednisolone 5 mg twice daily (16) Postmenopausal: tamoxifen 10 mg twice daily (72) vs. same + prednisolone 5 mg twice daily (73); treatment until PD; 204 randomized, 180 evaluable | 2 | Premenopausal/Postmenopausal response rates: 21% vs. 44% (ns)/13% vs. 36% responses (p < 0.01), median survival 19 vs. 18 months (ns)/12 vs. 21 months (p < 0.025) |
Rubens et al [46], 1988 | Only previous systemic therapy allowed was adjuvant chemotherapy (15%): ER/PgR unknown (23%) or ER+ve or PgR+ve | Premenopausal: ovarian irradiation with prednisolone 5 mg twice daily added on progression (NR/15) vs. ovarian irradiation + prednisolone 5 mg twice daily until PD (NR/16)/Postmenopausal: tamoxifen 10 mg twice daily changed to prednisolone 5 mg twice daily on progression (NR/78) vs. tamoxifen 10 mg twice daily +prednisolone 5 mg twice daily until PD (NR/85); 220 randomized/194 evaluable | 2 | Premenopausal/Postmenopausal response rates: 27% vs. 63% (p < 0.05)/31%vs46%(p < 0.1), median time to disease progression: 4 vs. 14 months (p = 0.006)/4 vs. 8 months (p = 0.02), median survival: 17 vs. 66 months (p = 0.04)/17.5 vs. 21 months (p = 0.3) |
Ingle et al, [7] 1991 | postmenopausal; ER/PR unknown (15%) or ER+ve or PgR+ve; only previous systemic therapy allowed was adjuvant chemotherapy (7.8%) | tamoxifen 10 mg po twice daily (162/159) vs. tamoxifen 10 mg po twice daily + prednisolone 5 mg po twice daily (164/161); continued until PD | 5 | responses in 38% vs. 47% (p = 0.15), median time to progression: 11 vs. 10 months (p = 0.81), median survival: 35 vs. 32 months (p = 0.40) |
Cocconi et al, [37] 1992 | postmenopausal; ER/PgR unknown (48%) or ER+ve or PgR+ve; no previous endocrine therapy for advanced disease; previous chemotherapy or endocrine therapy in 39% | aminoglutethimide 125 mg po twice daily for 1 month then 250 mg po twice daily (84/78) vs. same + hydrocortisone 20 mg po twice daily (87/83); treatment until PD | 3 | responses in 41% vs. 44% (ns), median time to progression: 6.3 vs. 8.1 months (p = 0.38), median survival: 36.3 vs. 34.2 months (p = 0.56) |
Randomized Controlled Trials of Glucocorticoids in the Endocrine Therapy of Breast Cancer in the Adjuvant Setting
Author [reference], Year | Patient Characteristics | Treatment Arms; Patient Number (Randomized/Evaluable) | Quality Score | Outcome(s) |
---|---|---|---|---|
DiMartino et al [9], 1991 | Postmenopausal | Tamoxifen 40 mg per day vs. same + prednisolone 7.5 mg per day; 67/57 vs. 49/47; treatment until recurrence | 1 | p values of 0.6743 and 0.2367 for differences in disease free survival and overall survival respectively |
Fentiman et al [6], 1994 | Postmenopausal | Tamoxifen 20 mg daily vs. same + prednisolone 7.5 mg daily; 186/173 vs. 184/168 | 2 | p values of 0.26 and 0.32 for differences in relapse free survival and overall survival respectively |
Meakin et al, [44], 1996 | no further treatment (NT) vs. ovarian irradiation (R) vs. (if ≥ 45) ovarian irradiation + prednisolone 7.5 mg daily up to 5 years (R +P); Premenopausal (≥ 45 years old) 64 vs. 71 vs. 73/Postmenopausal 136 vs. 111 vs. 111; 779 randomized, 703 analyzed as above | 1 | Premenopausal(≥ 45 years old)/Postmenopausal; median recurrence free survival (yrs): 9.4 vs. 18 vs. > 25/6.2 vs. 8.2 vs. 6.8; median survival (yrs): 12.8 vs. 14.9 vs. >25/9.3 vs. 9.9 vs. 7.7 | |
Scottish Cancer Trials Breast Group [13], 1993 | Premenopausal ER+ve 54%, ER status unknown 19% | Second randomization to prednisolone 7.5 mg po daily for 5 years vs. no prednisolone after first randomization to ovarian ablation vs. CMF (IV); 165/NR vs. 167/NR in second randomization | 3 | prednisolone effect did not depend on whether CMF or ovarian ablation (p = 0.46); hazard ratio and 95% CI for deaths for +/-prednisolone was 1.26 (0.86–1.84) |
Randomized Controlled Trials of Chemotherapy +/- Glucocorticoids in Advanced Breast Cancer
Author [reference], Year | Patient Characteristics | Treatment Arms Patient Number (Randomized/Evaluable) | Quality Score | Outcome(s) |
---|---|---|---|---|
Brambilla et al [17], 1974 | Postmenopausal | adriamycin 40–75 IV mg/m2 day 1, vincristine IV 1.4 mg/m2 days 1 and 8 every 3 weeks for 8 cycles (20/15) vs same + prednisone 100 po mg/m2/day days 1–5 (22/21) | 2 | response rates of 50% vs. 55% |
Ramirez et al [16], 1975 | 5-fluorouracil (5-FU) 10 mg/kg/week IV, methotrexate 0.5 mg/kg/week IV, vincristine 0.02 mg/kg/week IV, cyclophosphamide 2 mg/kg/day po (NR/52) vs. same + prednisone po 45 mg/day for 2 weeks, then 30 mg/day for 2 weeks then 15 mg/day (NR/48); treatment until PD | 2 | response rates of 44.2% vs. 62.5% (p = 0.075), no significant difference in response duration or survival | |
Rossi et al [25], 1976 | Pre or postmenopausal, no previous chemotherapy | L-phenylalanine 4 mg/m2 po/day + 5-FU 300 mg/m2 po/day each days 1–5 every 28 days (16/14) vs. same except 5-FU IV (18/18) vs. same as first except 5-FU IV + prednisone 30 mg/m2/day days 1–5 (17/15) | 1 | response rates of 7% vs. 22% vs. 40% (ns) |
Tormey et al [21], 1982 | Pre or postmenopausal, no previous chemotherapy or prednisone therapy | CMF (NR/79) vs. CMFP (NR/86) vs. AV (NR/166); after 6 months or if progressive disease prior to then, switched to nonglucocorticoid containing chemotherapy | 1 | response rates of 57% vs. 63% vs. 56% (p > 0.10), response durations of 4.5 months vs. 8.4 months vs. 7.7 months (p = 0.05), time to treatment failure of 5.3 months vs. 9.1 months vs. 5.7 months (p = 0.04), overall survival of 14.5 months vs. 16.4 months vs. 13.7 months (p = 0.03) |
Tormey et al [48], 1983 | Pre or postmenopausal, no previous chemotherapy or prednisone therapy | CMF (NR/47) vs. CMFP (NR/47) vs. rotation every 2 cycles between CMF and AV (NR/50); treatment for 6 months followed by nonglucocorticoid containing therapy | 2 | response rates of 55% vs. 70% vs. 58% (ns), response duration of CMF less than CMFP (p = 0.39); time to treatment failure of CMF 5.6 months and CMFP 7.0 months (p = 0.16); median survival of CMF 12.5 months and CMFP 18.0 months |
Gercovich et al [31], 1989 | Untreated | 5-FU + cyclophosphamide + mitoxantrone vs. same + prednisone 80 mg po days 1–5 (53/50 in total) | 1 | no difference in response rates |
Tashiro & Nomura [40], 1995 | resistant to or relapsed after adriamycin treatment, pre or postmenopausal | mitomycin C 4 mg/m2 + methotrexate 35 mg/m2 IV + vincristine 0.7 mg/m2 IV days 1 and 8 every 21 days (21/21) (MMV) vs. same + prednisolone 10 mg po per day (MMVP) (43/41) vs. same as first + MPA 1200 mg po per day (MMVM) (44/40); treatment until PD | 2 | response rates of 9.5% vs. 29% vs. 37.5% (p = 0.0784 comparing MMV to MMVP); median duration of response of 12 vs. 16 vs. 34 weeks (ns); time to progression for MMVM longer than MMVP which was longer than MMV (p = 0.0256); survival differences (p = 0.382) |
Piccart et al [28], 1997 | One previous chemotherapy regimen for advanced or metastatic breast cancer | docetaxel 50 mg/m2 IV days 1 and 8 every 3 weeks (42/41) vs. same + methylprednisolone 40 mg po on days -1,0,1,7,8 and 9 (41/39) | 2 | no significant differences in median response duration, median time to progression or median survival |
Randomized Controlled Trials of Chemotherapy +/- Glucocorticoids of Breast Cancer in the Adjuvant Setting
Author [reference], Year | Patient Characteristics | Treatment Arms Patient Number (Randomized/Evaluable) | Quality Score | Outcome(s) |
---|---|---|---|---|
Tormey et al [12], 1990 | Premenopausal, ER+ve 51%, ER-ve 49%, | CMF (222/188) vs. CMFP (220/183) vs. CMFP + tamoxifen 10 mg po twice daily(220/182), all treatments for one year | 2 | median time to relapse: CMF 6.2 months vs. CMFP 6.6 months (p = 0.64), survival: CMF vs. CMFP (p = 0.91) |
Ludwig Breast Cancer Study Group [53, 85], 1985 | pre and peri-menopausal, ER +ve 28%, ER -ve 24% ER unknown 48% | CMF (250/241) vs. CMF + prednisone 7.5 mg daily (255/250), all treatments for one year | 3 | 13 year disease-free survival of 52% vs. 49% (p = 0.39), 13 year overall survival of 65% vs. 59% (p = 0.30) |
Randomized Controlled Trials of Glucocorticoids in Prostate Cancer
Author [reference], Year | Patient Characteristics | Treatment Arms Patient Number (Randomized/Evaluable) | Quality Score | Outcome(s) |
---|---|---|---|---|
Sander et al [43], 1982 | Advanced untreated prostate cancer | orchiectomy (7/7) vs. ochiectomy + prednisone 2.5 mg po four times daily for 6 weeks (14/14) vs. ochiectomy + cyproterone acetate 50 mg po four times daily for 6 weeks (13/13) | 1 | response rates of 86% vs. 93% vs. 62% |
Williams et al [59], 1990 | Advanced untreated prostate cancer | orchiectomy (24/24) vs. orchiectomy + dexamethasone 0.5 mg in morning and 0.3 mg at night (16/16) vs. orchiectomy + cyproterone acetate 100 mg 3 times daily (20/20) | 3 | response rates of 33% vs. 62.5% vs. 45% at 1 year |
Fossa et al [33], 1985 | Hormone refractory prostate cancer | MPA 500 mg po twice daily (24/21) vs. prednisolone 5 mg po four times daily (24/24) | 2 | response rates of 38% vs. 13% (p < 0.05), no survival difference |
Patel et al [8], 1990 | Hormone refractory metastatic prostate cancer | Megestrol acetate 40 mg po four times daily (29/25) vs. dexamethasone 0.75 mg po twice daily (29/26), Treatment until PD | 2 | response rates of 10% vs. 7%, median survival of 268 vs. 246 days (p = 0.2) |
Datta et al [35], 1997 | Hormone refractory metastatic prostate cancer | Flutamide 250 mg three times daily (20/20) vs. prednisolone 5 mg twice daily (20/20) | 2 | PSA response rates of 50% vs. 55%, median survival of 30 vs. 36 weeks (p > 0.05) |
Tyrrell [36, 54, 60], 1996 | Hormone refractory advanced prostate cancer | prednisone 10 mg po twice daily (103/NR) vs. liarozole 300 mg po twice daily (117/NR) | 1 | PSA response rates of 25% vs. 18% (p = 0.31); time to PSA progression of 4.7 vs. 3.5 months; median survivals of 15.8 months vs. 11.7 months (p = 0.01) |
Fossa et al [32], 2001 | Hormone refractory metastatic prostate cancer | prednisone 5 mg po four times a day (101/95) vs. flutamide 250 mg po three times a day (100/96); treatment until PD | 2 | PSA responses of 21% vs. 23%, median time to progression of 3.4 months vs. 2.3 months (p = 0.0885); overall survival of 10.6 months vs. 11.2 months (p = 0.8370) |
Tombal et al [50], 2003 | Hormone refractory metastatic prostate cancer | irofulven (24 mg/m2 for first 18 patients then 0.55 mg/kg for next 43 patients) IV days 1 and 15 q4 weeks (29/28) vs. same + prednisone 10 mg daily (32/28) | 1 | PSA responses of 3/28 vs. 5/28 |
Randomized Controlled Trials of Glucocorticoids in GI Cancer
Author [reference], Year | Patient Characteristics | Treatment Arms Patient Number (Randomized/Evaluable) | Quality Score | Outcome(s) |
---|---|---|---|---|
Moertel et al [26], 1974 | GI cancer with expected survival of less than 2 months (61 colorectal, 22 gastric, 15 pancreatic, 9 hepatoma, 10 other) | placebo (47/NR) vs. dexamethasone 0.75 mg four times daily (33/NR) vs. dexamethasone 1.5 mg four times daily (36/NR); treatment until death or patient unable to take pills | 3 | Median survival (weeks) of 6.6 vs. 6.2 vs. 5.2 |
Reitemeier et al [20], 1967 | advanced GI cancer (37 gastric, 23 pancreatic, 52 unknown but presumed GI in origin) | fluorometholone 25 mg po every 12 hour for at least 2 months (34/32) vs. 5-FU IV 15 mg/kg/day for 5 consecutive days then 7.5 mg/kg/day every other day for a maximum of 4 additional doses (40/40) vs. 5-FU plus fluorometholone as just described (38/32) | 3 | response rates of 9% vs. 13% vs. 13%; average duration of response of 4 vs. 6.5 vs. 4 months |
Kemeny et al [11], 1992 | untreated colorectal cancer with only metastases being in liver | hepatic arterial FUDR 0.3 mg/kg/day for 14 of every 28 day cycle (25/25) vs. same plus hepatic arterial dexamethasone 20 mg over 14 days with the FUDR (25/24) | 3 | response rates of 40% vs. 71% (p = 0.03), median time to progression of 12 vs. 19 months (p = 0.58), median survival of 15 vs. 23 months (p = 0.06) |
Sato et al [51], 2002 | patients with esophageal squamous cell carcinoma scheduled to undergo esophageal resection | surgery (33/33) vs. surgery + 10 mg/kg methyprednisolone IV within 30 minutes of start of surgery (33/33) | 5 | p = 0.4465 for difference in overall survival rates 1 and 3 yr survival rates of 85% and 65% vs. 82% and 62% respectively |
Yano et al [58], 2005 | patients with thoracic esophageal cancer scheduled for esophagectomy | surgery (20/20) vs. surgery + methylprednisolone 500 mg IV 2 hours before surgery (20/20) | 3 | p = 0.3304 for difference in survival rates |
Randomized Controlled Trial of Glucocorticoids in Patients with Primary CNS Neoplasms
Author [reference], Year | Patient Characteristics | Treatment Arms Patient Number (Randomized/Evaluable) | Quality Score | Outcome(s) |
---|---|---|---|---|
Green et al [23], 1983 | after surgery for supratentorial malignant glioma; 6000 rads of radiation to start concurrently with medical therapy | BCNU 80 mg/m2/day IV for 3 consecutive days every 8 weeks (147/124) vs. methylprednisolone 400 mg/m2/day orally for 7 consecutive days every 4 weeks (156/141) vs. BCNU + methylprednisolone as previously described (153/134) vs. procarbazine 150 mg/m2/day orally for 28 consecutive days every 8 weeks (153/128) | 2 | 24 month survivals of 19.5% vs. 8.0% vs. 18.0% vs. 22.2%; in pairwise comparisons, only differences giving p < 0.05 were BCNU vs. methylprednisolone and procarbazine vs. methylprednisolone |
Randomized Controlled Trials of Glucocorticoids in Patients with GU Neoplasms
Randomized Controlled Trials and Meta-analysis of Glucocorticoids in Patients with a Variety of Cancers
Author [reference], Year | Patient Characteristics | Treatment Arms Patient Number (Randomized/Evaluable) | Quality Score | Outcome(s) |
---|---|---|---|---|
Della Cuna et al [30], 1989 | preterminal carcinoma; male (196): 38.8% lung, 12.8% stomach, 11.2% buccal cavity and pharynx, 7.1% prostate, 5.1% rectum/rectosigmoid junction female (207): 34.8% breast, 10.1% stomach, 11.1% large intestine, 7.7% cervix uteri, 5.3% lung, 5.3% rectum/rectosigmoid junction | methylprednisolone 125 mg IV daily for 8 weeks (207/NR) vs. placebo (196/NR) | 5 | mortality at 8 weeks: males 40.2% vs. 35.5%, females 40.0% vs. 27.7% (p < 0.01) |
Popiela et al [39], 1989 | terminal cancer, female, 85% with gastrointestinal or breast or genitourinary cancers, only solid tumors | methylprednisolone 125 mg IV daily for 56 days (85/NR) vs. placebo (88/NR) | 5 | mortality at 56 days of 38% vs. 30% (p > 0.05) |
Lundholm et al [14], 1994 | liver/pancreas 44, colorectal 30, gastric 18, esophagus 15, melanoma 7, breast 3, head and neck 3, miscellaneous 15 | indomethacin 50 mg po twice daily (45/NR) vs. prednisolone 10 mg po twice daily (45/NR) vs placebo (45/NR); all treatments until death | 2 | when all 3 groups compared simultaneously, survival of indomethacin > prednisone > placebo (p < 0.07) |
Loprinzi et al [49], 1999 | 40% lung cancer, 36% GI cancer, no breast or prostate or ovarian or endometrial cancer; | megestrol acetate 800 mg po every day (NR/158) vs. dexamethasone 0.75 mg po four times daily (NR/158) vs. fluoxymesterone 10 mg po twice daily (NR/159) | 2 | median survival of 126 days with no statistically significant difference between the 3 arms |
Mercadante et al [61], 2007 | advanced cancer patients on strong opioids | opioids vs. opioids + dexamethasone 8 mg po daily; 76 randomized/66 evaluable | 2 | Mean survival (range) of 33 (26-40) vs. 37 (28-45) days |
Feuer et al [62], 1999, Metaanalysis | patients with bowel obstruction due to malignancy; vast majority either gynecological or GI cancer | glucocorticoids (65/54) vs. no glucocorticoids (32/29) | Kaplan-Meier survival curves and 1 month survival: no differences of statistical significance | |
Horton et al [27], 1966 | 19 colorectal cancers, 13 adenocarcinomas of other primary sites, 10 miscellaneous cancers | 5-FU IV 15 mg/kg on 1st, 2nd, 3rd, 4th and 6th days and 7.5 mg/kg every other day thereafter until diarrhea, stomatitis or leukopenia (21/NR) vs. same + methyprednisolone 24 mg po daily (21/NR) | 4 | response rates of 24% vs. 19% |
Bernhardt et al [52], 2006 | cancers of lung (9), prostate (7), pancreas (3), ovary (2), breast (1), other (4) | docetaxel 75 mg/m2 day 8 of each 21 day cycle + perifosine 50 mg po 1 or 2 or 3 times a day in successive cohorts on days 1-14 vs. same + prednisone 5 mg twice daily | 1 | 2 SD (2 prostate) in 7 evaluable patients vs. 3 PR (1 lung and 2 prostate) and 1 SD (prostate) in 9 evaluable patients |
Sorensen et al [29], 1994 | patients with compression of spinal cord or cauda equina due to cancer: 34 breast cancers, 6 GI cancer, 5 prostate cancer, 3 lung cancer, 4 sarcoma, 2 melanoma, 1 each of kidney, mesothelioma and thyroid | radiation (30/30) vs. radiation + initial dose of dexamethasone 96 mg IV followed by dexamethasone 96 mg po daily for 3 days followed by 10 day taper (29/27) | 2 | median survival of 6 months in both arms |
Graham et al, [57], 2006 | patients with spinal cord compression not due to lymphoma or myeloma: 11 breast or prostate cancer, 9 lung or GI or renal or other | radiation + 16 mg of dexamethasone intravenously for 3 days followed by 13 day taper (9/9) vs. same except 96 mg of dexamethasone for first 3 days (11/11) | 1 | median survivals of 2.4 vs. 2.1 months |
Randomized Controlled Trials of Glucocorticoids in Lung Cancer
Author [reference], Year | Patient Characteristics | Treatment Arms Patient Number (Randomized/Evaluable) | Quality Score | Outcome(s) |
---|---|---|---|---|
Wolf et al [41, 42], 1960 | lung carcinoma not amenable to surgery or radiation therapy; distribution of the 4 tumor types (squamous, small cell, adenocarcinoma, large cell) between treatment groups did not statistically differ | Nitrogen mustard 0. 4 mg/kg IV days 1 and 42 (80/70) vs. testosterone propionate 100 mg IM three times weekly (106/99) vs. cortisone 100 mg po daily (86/78) vs. progesterone 2 mg po daily (91/83) vs. diethylstilbestrol 10 mg po daily (89/82) vs. placebo po daily (88/84); all treatments (except for nitrogen mustard) for 12 weeks followed by 8 week taper for oral treatments | 4 | median survival (days) of 121 vs. 78 vs. 56 vs. 60 vs. 75 vs. 93 |
Macbeth et al [10], 1994 | nonsmall cell and small cell lung cancer | 76/72 to either megestrol acetate 480 mg/m2 or prednisolone 15 mg/m2 for 8 weeks; no radiation with a curative intent or chemotherapy given | 2 | survival worse in the megestrol acetate arm (p = 0.02) |
Thatcher et al [34], 1982 | metastatic nonsmall cell and small cell lung cancer; no previous chemotherapy or steroids | Cyclophosphamide IV 1.5 g/m2, 2.5 g/m2, 3.5 g/m2 each separated by 3 weeks (28/28, 16 SCLC) vs. same + prednisolone 100 mg/m2 orally on day of and day after each chemotherapy (29/29, 16 SCLC) | 2 | response rates of 57% vs. 24%, median duration of response (weeks) of 15 vs. 11 (p > 0.05), median survival (weeks) of 24 vs. 14 (p = 0.004) |
Leggas et al [89], 2005 | untreated Stage lV NSCLC | 4 cycles of carboplatin AUC 5.5 day 1 and gemcitabine 1000 mg/m2 days 1 and 8 every 21 days; 4 days prior to and the day of each chemotherapy treatment in courses 2-4, dexamethasone 16 mg bid (NR/12) vs. 8 mg bid (NR/12) vs none (NR/6) | 8 PR vs. 7 PR vs. 2 PR |