002) and with the IGF-I response to previous therapy reflected in the ∆ IGF-I (p?=?0.001) (Table 2). Table 2 Logistic regression analysis: variables determining the decision to prescribe PEGV with or without SSA therapy (dependent variable) COVARIATES OR (95% CI) P GH at baseline (μg/L) 1.015 (0.983-1.043) 1.047 IGF-I SDS at baseline 1.003 (0.999-1.007) 0.097 Δ IGF I a SDS 1.446 (1.153-1.814) 0.001 Detectable adenoma at baseline b 13.757 (2.547-74.307) 0.002 Abbreviations: CI confidence intervals, OR odds ratios, PEGV pegvisomant, SSA somatostatin analogs. a SDS observed at diagnosis minus SDS observed at baseline. b Includes
patients who had not had surgery and those who had undergone surgery but presented residual tumor at baseline. Table 3 shows the treatment outcomes and adverse effects (AEs) reported during follow-up. The duration of PEGV therapy was significantly longer in Group 1 (p?3). None of the patients on monotherapy selleck chemicals displayed significant tumor growth, and in one case MRI documented progressive shrinkage of the adenoma, which was no longer detectable after 6 years of treatment. In Group 2, significant growth
(> 25%) of residual adenoma tissue was observed in only one case. The patient had always had very aggressive disease that was difficult/impossible to control, and this website when the tumor enlargement was noted, he was receiving PEGV 40 mg/day plus lanreotide ATG 120 mg every 4 weeks. Eight (12.9%) patients (five in Group 1, three in Group 2) experienced significant hypertransaminasemia. Six of these had diabetes, and five had elevated IGF-I levels at end of follow-up.
Daily PEGV doses at the time of the hypertransaminasemia varied: three patients were receiving 30 mg, four were taking 15 mg, and one was on 10 mg /day. All episodes Protirelin resolved spontaneously without treatment interruption or dose reductions. Two AEs at the injection site were observed (one in each group). Table 3 End-of-follow-up findings in Groups 1 and 2 Group 1 PEGV Group 2 PEGV?+?SSA Patients – n (%) 35 (56.4) 27 (43.6) Duration (mo.) of PEGV therapy – median (range) 51 (15–72) 30 (6–72)* Final weekly PEGV dose (mg) – median (range) 105 (70–210) 140 (70–280) Final daily PEGV dose (mg) 10 mg – n (%) 10 (28.6) 11(40.7) 15 mg – n (%) 11 (31.4) 2 (7.4) 20 mg – n (%) 9 (25.7) 8 (29.6) 25 mg – n (%) 1 (2.8) 1 (3.7) 30 mg – n (%) 4 (11.4) 4 (14.8) 40 mg – n (%) 0 (0) 1 (3.7) Group mean (±SD) 16.8 (±6.3) 17.9 (±8.4) Group median (range) 15 (10–30) 20 (10–40) Subgroup with IGF-I LDN-193189 order normalization at end of follow-up 15 (10–30) 10 (10–30) Subgroup with abnormal IGF-I levels at end of follow-up 15 (10–20) 20 (10–40)*# Pts. requiring dose reduction during follow-up a – n (%) 5 (14.3) 4 (14.8) Pts. with IGF-I normalization at any time during follow-up b – n (%) 29 (82.8) 18 (66.7) Pts. with IGF-I normalization at end of follow-up – n (%) 28 (80) 15 (55.5)* Final IGF-I levels μg/L,Median (range) 212 (110–1216)# 291 (150–1015)*# SDS (range) 1.0 (−0.5–14.1)# 1.