| Author |
Cascinu 1995 |
Cunningham 1998 |
Glimelius 1997 |
Scheithauer 1993 |
| Symptom control |
Every two weeks patients of both arms were looked after in the same setting by the same physician and nursing staff in order to record both side effects of treatment with octreotide and possible complications related to neoplastic disease. No further sub group analysis |
Localised radiation therapy to alleviate symptoms such as pain was allowed provided that the total dose delivered was in the palliative range according to institutional standards |
T1: Treating physician considered 17 (55%) patients to have had either a prolonged symptom‐free period or improved symptomatology in the absence of severe toxicity. T2: 6(20%, P < 0.01) |
Chemotherapy Group: 2 patients had to have the dose reduced by 25% because of grade 3 haematological and gastrointestinal side effects |
| Pain severity and pain relief |
No sub group analysis. Only five patients suffered from pain at injection sites, but it did not determine the refusal of treatment or reduce their compliance in taking the drug octreotide |
T1: Pain free survival in patients without pain was significantly longer versus T2: (P = 0.003), despite a higher proportion of patients on opioids in the supportive care group. Worst score during study for EORTC QLQ C30 pain scale mean (SE) 39.98 (2.39) versus 53.42 (3.27), P = 0.001 |
T1 versus T2: The average scores on most scale items and global health status did not differ between two groups at randomistaion although there were more problems with pain and nausea/vomiting in chemotherapy group |
Not reported |
| Any reported adverse effects |
No sub group analysis. T1: No severe toxicity recorded requiring discontinuation of octreotide. 20 patients had asymptomatic hyperglycaemia, ten patients mild steatorrhoea, three patients had abdominal cramps‐disappeared spontaneously after few days of continued therapy |
T1: Significantly more patients experienced severe events, especially neutropenia, nausea, vomiting and diarrhoea. T2: High incidence of severe adverse events (drug related or not), especially pain and asthenia. T1: 2(1.1%) of 183 patients died of drug‐related causes although in one, the association with adverse events (diarrhoea and/or febrile neutropenia) has not been clearly established |
FLv treatment: toxicity was low. ELF treatment: toxicity was higher with grade 3/4 toxicities (except alopecia in five (22%) patients.ELF treated patients: had more or less total alopecia. No toxic deaths reported. One patient alive in each group at end of follow‐up |
T1: Toxicity was common, symptoms were generally mild‐moderate. No patient stopped chemotherapy due to side effects. T2: mild nausea, diarrhoea, and infection were indicated by 2, 3, and 1 patient respectively. No other toxicities were recorded |
| Hospitalisation due to adverse effects |
No patients in either arm developed infections requiring hospitalisation |
T1: Admission for adverse events occurred in T1: 136 (72%) of patients (cumulative median: 15 days, range one to 168 days) versus T2: 57 (63%) of patients (cumulative median 11 days, range two to 87 days) |
Not Reported |
Not Reported |
| Withdrawals and dropouts |
T1: four gastric cancer patients received octreotide for only six weeks, due to severe impairment of general conditions owing to rapid disease progression and died only after two weeks. |
T1: n = 189 (six did not receive study medication, five lost to follow up, 123 died, 61 alive). T2: n = 90 (five patients lost to follow‐up, 71 died, 14 alive) |
Two patients in each group did not complete the questionnaire at randomisation due to rapidly progressing disease. Number of patients replying to questionnaire declined during follow‐up, decline was more rapid in T2 (reasons for not replying to a questionnaire after two and four months were usually either death or that patient was terminally ill). After first interview, one patient in T2 refused further interviews |
Forty patients were accrued to study. Two patients in each treatment arm refused to accept the treatment assigned or participate in the study, or both (thus 36 patients were eligible for analysis of response and toxicity. Thirty three of 36 patients in study had died at the end of study period. T1: 21 (87%) versus T2 : 12. The minimum follow‐up of survivors was 28 months |
| Disease progression |
Stable Disease: T1: 25 (seven stomach, seven pancreas, 11 colon‐rectum) (45%) patients showed stable disease versus only T2: eight (three stomach, two pancreas, three colon rectum) (15%), (P < 0.001) |
Patients had proven metastatic colorectal cancer which had progressed within six months of treatment with 5FU. No further information on disease progression during or after the trial |
T1: The median time to disease progression was six (zero to20+) months versus T2: 2 (zero to 14) months (P < 0.01). The median time to objective disease progression (or deaths in patients not objectively evaluated was T1:six (zero to20+) months vs. T2: two (zero to 13) months (P = 0.03) |
T1: Of 24 patients randomised eight partially responded, the median duration of response was T1:35 (16 to 56) weeks. Nine patients (38%) had stable disease, seven (29%) had progressive disease versus T2: three (25%) of 12 patients were classified as having stable disease, nine (75%) as having progressive disease. Median time to progression: T1: 6.0 (12 to 14) months, versus T2: 2.3 (1.5 to 8.0) months, statistically significant difference (P = 0.0008) |
