3. Synthetic thymic peptides: survival, response, toxicity.
Study | Survival rates | Tumour response | Toxicity (no. of patients) | |||
OS | DFS | CR | PR | Grade 3/4 neutropenia | Grade 3/4 infection | |
Maio 2010 |
At 1 year:
IG1 (IFN ɑ+1.6 mg thymosin α1): 39/97 (40%)
IG2 (IFN ɑ+3.2 mg thymosin α1): 36/97 (37%)
IG3 (IFN ɑ+6.4 mg thymosin α1): 45/98 (46%)
IG4 (3.2 mg thymosin α1)*: 38/99 (39%) total IG (IG1‐3): 120/292 (41%) CG (IFN ɑ): 33/97 (34%) |
At 1 year#: IG1: 4/97 (4%) IG2: 10/97 (10%) IG3: 3/98 (3%) IG4*: 10/99 (10%) total IG (IG1‐3): 17/292 (5%) CG: 0/97 |
Best response within 12 months (measured at various time points):
IG1: 2/97 (2%)
IG2: 3/97 (3%)
IG3: 2/98 (3%)
IG4*: 2/99 (2%) total IG (IG1‐3): 7/292 (2%) CG: 0/97 |
IG1: 5/97 (5%) IG2: 7/97 (7%) IG3: 4/98 (4%) IG4*: 10/99 (10%) total IG (IG1‐3): 16/292 (5%) CG: 4/97 (4%) | n.r. | |
Cheng 2004 | After a median time of survival in IG of 10 months§: IG: 9/18 (50%) CG: 9/23 (39%) | At 1 year: IG: 3/18 (17%) CG: 3/23 (13%)(n.s.) | n.r. | n.r. | ||
Gebbia 1994 | n.r. | n.r. | n.r. | (ANC<1,000/mm² and fever>38°C) IG1 (thymopentin): 12/23 (52%) IG2 (thymopentin+G‐CSF): 4/22 (18%) IG1+IG2: 16/45 (36%) CG1 (placebo): 18/28 (64%) CG2 (G‐CSF): 5/23 (22%) CG1+CG2: 23/51 (45%) | ||
Gish 2009 | At 6 months IG: 12/14 (86%) CG: 7/11 (64%) | n.r. | Best response within 18 months (measured at various time points): IG: 0/14 CG: 0/11 | IG: 2/14 (14%) CG: 2/11 (18%) | n.r. | (severe bacterial infections) IG: 0/14 CG: 4/11 (36%) |
At 12 months IG: 9/14 (64%) CG: 7/11 (64%) | ||||||
At 2 years IG: 8/14 (57%) CG: 5/11 (45%) | ||||||
GISOT 1987 | After 3 months mean observation time: IG: 432/447 (97%) CG:197/203 (97%) (P = 0,068, chi²) | n.r. | n.r. | n.r. | ||
Schulof 1985 | After 1 year#: IG1 (maintenance therapy): 8/15 (53%) IG2 (loading dose): 4/13 (31%) CG: 1/13 (8%) | After 1 year#: IG1: 3/15 (20%) IG2: 4/13 (31%) CG: 0/13 | n.r. | n.r. |
Abbreviations: # survival rates extracted from Kaplan‐Meier curves, § survival rates estimated from median survival times, * not included in metaanalysis; CR: complete remission, PR: partial remission, SD: stable disease, NC: no change, PD: progressive disease