Trial Outcomes & Findings for A Study Comparing Treatment With 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in Patients With Inoperable, Progressive, Somatostatin Receptor Positive Midgut Carcinoid Tumours (NCT NCT01578239)

Last Updated: 2022-04-04

Results Overview

Progression Free Survival (PFS) was defined as the time from randomization to documented centrally assessed disease progression, as evaluated by the Independent Review Committee (IRC), or death due to any cause. If a participant had no centrally assessed progression and had not died at the time of the primary endpoint analysis, the participant was regarded as censored in the context of a time to event analysis at the date of last evaluable tumor assessment. Disease progression was determined by objective tumor response status using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

231 participants

Primary outcome timeframe

From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached on 24July2015, assessed up to approximately 34 months

Results posted on

2022-04-04

Participant Flow

The study was conducted in 41 sites across 8 countries.

Participant milestones

Participant milestones
Measure	177Lu-DOTA0-Tyr3-Octreotate * 30 mg Octreotide LAR treatment for symptom control continued until the end of study, unless the participant progressed or died. * Treatment consisted of a cumulative administered radioactivity of 29.6 Giga Becquerel (GBq) (800 mCi) 177Lu-DOTA0-Tyr3-Octreotate: Four administrations of 7.4 GBq (200 mCi). * Concomitant amino acids were given with each administration for kidney protection. * 177Lu-DOTA0-Tyr3-Octreotate was administered at 8 +/- 1-week intervals, which could be extended up to 16 weeks to accommodate resolving acute toxicity. * In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, Octreotide s.c. rescue injections were allowed.	Octreotide LAR * 60 mg Octreotide LAR treatment every 4 weeks (i.m. injections) until the end of the study, unless the participant progressed or died. * In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, s.c. Octreotide rescue injections were allowed.
Treatment Period STARTED	117	114
Treatment Period Full Analysis Set (FAS)	117	114
Treatment Period Safety Analysis Set (SAF)	111	112
Treatment Period FAS-Entered Long-term Follow-up	101	99
Treatment Period COMPLETED	50	13
Treatment Period NOT COMPLETED	67	101
Long-term Follow-Up Period STARTED	101	99
Long-term Follow-Up Period COMPLETED	24	19
Long-term Follow-Up Period NOT COMPLETED	77	80

Reasons for withdrawal

Reasons for withdrawal
Measure	177Lu-DOTA0-Tyr3-Octreotate * 30 mg Octreotide LAR treatment for symptom control continued until the end of study, unless the participant progressed or died. * Treatment consisted of a cumulative administered radioactivity of 29.6 Giga Becquerel (GBq) (800 mCi) 177Lu-DOTA0-Tyr3-Octreotate: Four administrations of 7.4 GBq (200 mCi). * Concomitant amino acids were given with each administration for kidney protection. * 177Lu-DOTA0-Tyr3-Octreotate was administered at 8 +/- 1-week intervals, which could be extended up to 16 weeks to accommodate resolving acute toxicity. * In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, Octreotide s.c. rescue injections were allowed.	Octreotide LAR * 60 mg Octreotide LAR treatment every 4 weeks (i.m. injections) until the end of the study, unless the participant progressed or died. * In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, s.c. Octreotide rescue injections were allowed.
Treatment Period Progressive Disease	19	64
Treatment Period Physician Decision	17	17
Treatment Period Adverse Event	13	10
Treatment Period Non-compliance	2	0
Treatment Period Withdrawal by Subject	10	9
Treatment Period Other	6	1
Long-term Follow-Up Period Death	69	64
Long-term Follow-Up Period Consent withdrawal	4	10
Long-term Follow-Up Period Lost to Follow-up	2	4
Long-term Follow-Up Period Other	2	2

Baseline Characteristics

A Study Comparing Treatment With 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in Patients With Inoperable, Progressive, Somatostatin Receptor Positive Midgut Carcinoid Tumours

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	177Lu-DOTA0-Tyr3-Octreotate n=117 Participants * 30 mg Octreotide LAR treatment for symptom control continued until the end of study, unless the participant progressed or died. * Treatment consisted of a cumulative administered radioactivity of 29.6 Giga Becquerel (GBq) (800 mCi) 177Lu-DOTA0-Tyr3-Octreotate: Four administrations of 7.4 GBq (200 mCi). * Concomitant amino acids were given with each administration for kidney protection. * 177Lu-DOTA0-Tyr3-Octreotate was administered at 8 +/- 1-week intervals, which could be extended up to 16 weeks to accommodate resolving acute toxicity. * In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, Octreotide s.c. rescue injections were allowed.	Octreotide LAR n=114 Participants * 60 mg Octreotide LAR treatment every 4 weeks (i.m. injections) until the end of the study, unless the participant progressed or died. * In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, s.c. Octreotide rescue injections were allowed.	Total n=231 Participants Total of all reporting groups
Age, Continuous	63.4 years STANDARD_DEVIATION 9.34 • n=5 Participants	64.0 years STANDARD_DEVIATION 9.80 • n=7 Participants	63.7 years STANDARD_DEVIATION 9.55 • n=5 Participants
Sex: Female, Male Female	54 Participants n=5 Participants	60 Participants n=7 Participants	114 Participants n=5 Participants
Sex: Female, Male Male	63 Participants n=5 Participants	54 Participants n=7 Participants	117 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized White	93 Participants n=5 Participants	96 Participants n=7 Participants	189 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Not Applicable	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached on 24July2015, assessed up to approximately 34 months

Population: Full Analysis Set (FAS).

Outcome measures

Outcome measures
Measure	177Lu-DOTA0-Tyr3-Octreotate n=117 Participants * 30 mg Octreotide LAR treatment for symptom control continued until the end of study, unless the participant progressed or died. * Treatment consisted of a cumulative administered radioactivity of 29.6 Giga Becquerel (GBq) (800 mCi) 177Lu-DOTA0-Tyr3-Octreotate: Four administrations of 7.4 GBq (200 mCi). * Concomitant amino acids were given with each administration for kidney protection. * 177Lu-DOTA0-Tyr3-Octreotate was administered at 8 +/- 1-week intervals, which could be extended up to 16 weeks to accommodate resolving acute toxicity. * In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, Octreotide s.c. rescue injections were allowed.	Octreotide LAR n=114 Participants * 60 mg Octreotide LAR treatment every 4 weeks (i.m. injections) until the end of the study, unless the participant progressed or died. * In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, s.c. Octreotide rescue injections were allowed.
Progression Free Survival (PFS)	NA months NA: not estimable due to number of censored participants at the time the analysis cut off date was reached.	8.5 months Interval 5.8 to 9.1

SECONDARY outcome

Timeframe: From date of randomization until date of progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached on 24July2015, assessed up to approximately 34 months

Population: Full Analysis Set (FAS). Only participants with available post-baseline CT scans were considered.

Objective Response Rate (ORR) was calculated as the proportion of patients with tumour size reduction (sum of partial responses (PR) and complete responses (CR)) according to RECIST 1.1.

Outcome measures

Outcome measures
Measure	177Lu-DOTA0-Tyr3-Octreotate n=102 Participants * 30 mg Octreotide LAR treatment for symptom control continued until the end of study, unless the participant progressed or died. * Treatment consisted of a cumulative administered radioactivity of 29.6 Giga Becquerel (GBq) (800 mCi) 177Lu-DOTA0-Tyr3-Octreotate: Four administrations of 7.4 GBq (200 mCi). * Concomitant amino acids were given with each administration for kidney protection. * 177Lu-DOTA0-Tyr3-Octreotate was administered at 8 +/- 1-week intervals, which could be extended up to 16 weeks to accommodate resolving acute toxicity. * In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, Octreotide s.c. rescue injections were allowed.	Octreotide LAR n=100 Participants * 60 mg Octreotide LAR treatment every 4 weeks (i.m. injections) until the end of the study, unless the participant progressed or died. * In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, s.c. Octreotide rescue injections were allowed.
Objective Response Rate (ORR)	14.7 Percentage of Participants Interval 7.8 to 21.6	4.0 Percentage of Participants Interval 0.2 to 7.8

SECONDARY outcome

Timeframe: From date of randomization until date of death from any cause up to final safety cut-off date reached on 18Jan2021, assessed up to approximately 100 months

Population: Full Analysis Set (FAS).

Overall Survival (OS) was defined as the time from the date of randomization to the date of death due to any cause or the date of last contact (censored observation) prior to the date of the data cut-off, and during the entire study period (i.e. the treatment period plus follow-up).

Outcome measures

Outcome measures
Measure	177Lu-DOTA0-Tyr3-Octreotate n=117 Participants * 30 mg Octreotide LAR treatment for symptom control continued until the end of study, unless the participant progressed or died. * Treatment consisted of a cumulative administered radioactivity of 29.6 Giga Becquerel (GBq) (800 mCi) 177Lu-DOTA0-Tyr3-Octreotate: Four administrations of 7.4 GBq (200 mCi). * Concomitant amino acids were given with each administration for kidney protection. * 177Lu-DOTA0-Tyr3-Octreotate was administered at 8 +/- 1-week intervals, which could be extended up to 16 weeks to accommodate resolving acute toxicity. * In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, Octreotide s.c. rescue injections were allowed.	Octreotide LAR n=114 Participants * 60 mg Octreotide LAR treatment every 4 weeks (i.m. injections) until the end of the study, unless the participant progressed or died. * In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, s.c. Octreotide rescue injections were allowed.
Overall Survival (OS)	48.0 Months Interval 37.4 to 55.2	36.3 Months Interval 25.9 to 51.7

SECONDARY outcome

Timeframe: 12 months, 24 months, 36 months, 48 months, 60 months

Population: Full Analysis Set (FAS).

Survival estimates were collected every 12 Months up to 60 Months to compare OS between the two treatment groups.

Outcome measures

Outcome measures
Measure	177Lu-DOTA0-Tyr3-Octreotate n=117 Participants * 30 mg Octreotide LAR treatment for symptom control continued until the end of study, unless the participant progressed or died. * Treatment consisted of a cumulative administered radioactivity of 29.6 Giga Becquerel (GBq) (800 mCi) 177Lu-DOTA0-Tyr3-Octreotate: Four administrations of 7.4 GBq (200 mCi). * Concomitant amino acids were given with each administration for kidney protection. * 177Lu-DOTA0-Tyr3-Octreotate was administered at 8 +/- 1-week intervals, which could be extended up to 16 weeks to accommodate resolving acute toxicity. * In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, Octreotide s.c. rescue injections were allowed.	Octreotide LAR n=114 Participants * 60 mg Octreotide LAR treatment every 4 weeks (i.m. injections) until the end of the study, unless the participant progressed or died. * In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, s.c. Octreotide rescue injections were allowed.
Rate of Overall Survival (OS) 12 months	91.0 Percentage of Survival Estimates Interval 84.0 to 95.1	79.7 Percentage of Survival Estimates Interval 70.8 to 86.1
Rate of Overall Survival (OS) 24 months	76.0 Percentage of Survival Estimates Interval 66.7 to 83.0	62.7 Percentage of Survival Estimates Interval 52.6 to 71.2
Rate of Overall Survival (OS) 36 months	61.4 Percentage of Survival Estimates Interval 51.4 to 69.9	50.1 Percentage of Survival Estimates Interval 40.0 to 59.4
Rate of Overall Survival (OS) 48 months	49.5 Percentage of Survival Estimates Interval 39.5 to 58.6	41.8 Percentage of Survival Estimates Interval 31.8 to 51.4
Rate of Overall Survival (OS) 60 months	37.1 Percentage of Survival Estimates Interval 27.8 to 46.4	35.4 Percentage of Survival Estimates Interval 25.7 to 45.2

SECONDARY outcome

Population: Full Analysis Set (FAS).

Time to Tumour Progression (TTP) was defined as the time from randomization to progression centrally assessed. It included patients who dropped out due to toxicity, but omitted patients who died without measured progression (censored to last follow-up date or death date).

Outcome measures

Outcome measures
Measure	177Lu-DOTA0-Tyr3-Octreotate n=117 Participants * 30 mg Octreotide LAR treatment for symptom control continued until the end of study, unless the participant progressed or died. * Treatment consisted of a cumulative administered radioactivity of 29.6 Giga Becquerel (GBq) (800 mCi) 177Lu-DOTA0-Tyr3-Octreotate: Four administrations of 7.4 GBq (200 mCi). * Concomitant amino acids were given with each administration for kidney protection. * 177Lu-DOTA0-Tyr3-Octreotate was administered at 8 +/- 1-week intervals, which could be extended up to 16 weeks to accommodate resolving acute toxicity. * In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, Octreotide s.c. rescue injections were allowed.	Octreotide LAR n=114 Participants * 60 mg Octreotide LAR treatment every 4 weeks (i.m. injections) until the end of the study, unless the participant progressed or died. * In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, s.c. Octreotide rescue injections were allowed.
Time to Tumour Progression (TTP)	NA Months NA: not estimable due to number of censored participants at the time the analysis cut off date was reached.	8.7 Months Interval 6.0 to 11.1

SECONDARY outcome

Population: Full Analysis Set (FAS). Only Participants with an Objective Response are included in the analysis.

The Duration of Response (DoR) was defined as the time from initially meeting the criteria for response (CR or PR) until the time of progression by RECIST 1.1.

Outcome measures

Outcome measures
Measure	177Lu-DOTA0-Tyr3-Octreotate n=15 Participants * 30 mg Octreotide LAR treatment for symptom control continued until the end of study, unless the participant progressed or died. * Treatment consisted of a cumulative administered radioactivity of 29.6 Giga Becquerel (GBq) (800 mCi) 177Lu-DOTA0-Tyr3-Octreotate: Four administrations of 7.4 GBq (200 mCi). * Concomitant amino acids were given with each administration for kidney protection. * 177Lu-DOTA0-Tyr3-Octreotate was administered at 8 +/- 1-week intervals, which could be extended up to 16 weeks to accommodate resolving acute toxicity. * In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, Octreotide s.c. rescue injections were allowed.	Octreotide LAR n=4 Participants * 60 mg Octreotide LAR treatment every 4 weeks (i.m. injections) until the end of the study, unless the participant progressed or died. * In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, s.c. Octreotide rescue injections were allowed.
Duration of Response (DoR)	NA Months Interval 2.8 to NA: not estimable due to number of censored participants at the time the analysis cut off date was reached.	1.9 Months Interval 1.9 to NA: not estimable due to number of censored participants at the time the analysis cut off date was reached.

SECONDARY outcome

Timeframe: From informed consent signature through study completion reached at final safety cutoff date on 18July2021, assessed up to approximately 101 Months

Population: Safety Analysis Set (SAF).

The distribution of adverse events was done via the analysis of frequencies for Adverse Event (AEs), Serious Adverse Event (SAEs) and Deaths, through the monitoring of relevant clinical and laboratory safety parameters.

Outcome measures

Outcome measures
Measure	177Lu-DOTA0-Tyr3-Octreotate n=111 Participants * 30 mg Octreotide LAR treatment for symptom control continued until the end of study, unless the participant progressed or died. * Treatment consisted of a cumulative administered radioactivity of 29.6 Giga Becquerel (GBq) (800 mCi) 177Lu-DOTA0-Tyr3-Octreotate: Four administrations of 7.4 GBq (200 mCi). * Concomitant amino acids were given with each administration for kidney protection. * 177Lu-DOTA0-Tyr3-Octreotate was administered at 8 +/- 1-week intervals, which could be extended up to 16 weeks to accommodate resolving acute toxicity. * In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, Octreotide s.c. rescue injections were allowed.	Octreotide LAR n=112 Participants * 60 mg Octreotide LAR treatment every 4 weeks (i.m. injections) until the end of the study, unless the participant progressed or died. * In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, s.c. Octreotide rescue injections were allowed.
Number of Participants With Adverse Events Adverse Events (AEs)	105 Participants	90 Participants
Number of Participants With Adverse Events Serious Adverse Events (SAEs)	40 Participants	31 Participants
Number of Participants With Adverse Events Deaths during treatment period	4 Participants	5 Participants
Number of Participants With Adverse Events Deaths during follow-up period	66 Participants	63 Participants

SECONDARY outcome

Timeframe: Inclusion (Baseline) (BL), Week 72, Week 120

Population: Safety Analysis Set (SAF). Values at Inclusion were taken from last non-missing value prior to randomization (the only scheduled pre-randomization assessment was at the Baseline visit). Calculations at each visit included only participants with scores at the visit and Inclusion.

The Quality of Life Questionnaire C30 (QLQ-C30) was developed by the European Organization for Research and Treatment of Cancer (EORTC) to assess quality of life in cancer patients. It includes five function domains (physical, emotional, social, role, cognitive), eight symptoms (fatigue, pain, nausea/vomiting, constipation, diarrhea, insomnia, dyspnea, and appetite loss), as well as global health/quality-of-life and financial impact. Subjects respond on a four-point scale from "not at all" to "very much" for most items. Raw scores are linearly transformed so each score ranged a 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).

Outcome measures

Outcome measures
Measure	177Lu-DOTA0-Tyr3-Octreotate n=111 Participants * 30 mg Octreotide LAR treatment for symptom control continued until the end of study, unless the participant progressed or died. * Treatment consisted of a cumulative administered radioactivity of 29.6 Giga Becquerel (GBq) (800 mCi) 177Lu-DOTA0-Tyr3-Octreotate: Four administrations of 7.4 GBq (200 mCi). * Concomitant amino acids were given with each administration for kidney protection. * 177Lu-DOTA0-Tyr3-Octreotate was administered at 8 +/- 1-week intervals, which could be extended up to 16 weeks to accommodate resolving acute toxicity. * In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, Octreotide s.c. rescue injections were allowed.	Octreotide LAR n=112 Participants * 60 mg Octreotide LAR treatment every 4 weeks (i.m. injections) until the end of the study, unless the participant progressed or died. * In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, s.c. Octreotide rescue injections were allowed.
Change From Baseline in the EORTC QLQ-C30 Questionnaire Physical functioning: chg from BL @ wk 72 (n=33,11)	3.232 Scores on a scale Standard Deviation 12.4857	-4.242 Scores on a scale Standard Deviation 10.0101
Change From Baseline in the EORTC QLQ-C30 Questionnaire Physical functioning: chg from BL @ wk 120 (n=2,0)	-3.333 Scores on a scale Standard Deviation 4.7140	—
Change From Baseline in the EORTC QLQ-C30 Questionnaire Role functioning: chg from BL @ wk 72 (n=33,11)	5.051 Scores on a scale Standard Deviation 33.1989	-3.030 Scores on a scale Standard Deviation 16.3608
Change From Baseline in the EORTC QLQ-C30 Questionnaire Role functioning: chg from BL @ wk 120 (n=2,0)	8.333 Scores on a scale Standard Deviation 11.7851	—
Change From Baseline in the EORTC QLQ-C30 Questionnaire Emotional functioning: chg from BL @ wk 72 (n=33,11)	7.744 Scores on a scale Standard Deviation 22.6602	6.061 Scores on a scale Standard Deviation 17.9083
Change From Baseline in the EORTC QLQ-C30 Questionnaire Emotional functioning: chg from BL @ wk 120 (n=2,0)	12.500 Scores on a scale Standard Deviation 5.8926	—
Change From Baseline in the EORTC QLQ-C30 Questionnaire Cognitive functioning: chg from BL @ wk 72 (n=33,11)	5.556 Scores on a scale Standard Deviation 15.9571	1.515 Scores on a scale Standard Deviation 13.8535
Change From Baseline in the EORTC QLQ-C30 Questionnaire Cognitive functioning: chg from BL @ wk 120 (n=2,0)	16.667 Scores on a scale Standard Deviation 23.5702	—
Change From Baseline in the EORTC QLQ-C30 Questionnaire Social functioning: chg from BL @ wk 72 (n=33,11)	8.586 Scores on a scale Standard Deviation 28.9039	-7.576 Scores on a scale Standard Deviation 18.8025
Change From Baseline in the EORTC QLQ-C30 Questionnaire Social functioning: chg from BL @ wk 120 (n=2,0)	8.333 Scores on a scale Standard Deviation 35.3553	—
Change From Baseline in the EORTC QLQ-C30 Questionnaire Global Health Status/QoL: chg from BL @ wk 72 (n=33,11)	5.556 Scores on a scale Standard Deviation 21.4155	1.515 Scores on a scale Standard Deviation 10.4205
Change From Baseline in the EORTC QLQ-C30 Questionnaire Global Health Status/QoL: chg from BL @ wk 120 (n=2,0)	-16.667 Scores on a scale Standard Deviation 0.0000	—
Change From Baseline in the EORTC QLQ-C30 Questionnaire Fatigue: chg from BL @ wk 72 (n=33,11)	-7.239 Scores on a scale Standard Deviation 24.7084	-2.020 Scores on a scale Standard Deviation 13.8939
Change From Baseline in the EORTC QLQ-C30 Questionnaire Fatigue: chg from BL @ wk 120 (n=2,0)	11.111 Scores on a scale Standard Deviation 0.0000	—
Change From Baseline in the EORTC QLQ-C30 Questionnaire Nausea & Vomiting: chg from BL @ wk 72 (n=33,11)	-4.545 Scores on a scale Standard Deviation 15.1799	-4.545 Scores on a scale Standard Deviation 7.7850
Change From Baseline in the EORTC QLQ-C30 Questionnaire Nausea & Vomiting: chg from BL @ wk 120 (n=2,0)	0.000 Scores on a scale Standard Deviation 0.0000	—
Change From Baseline in the EORTC QLQ-C30 Questionnaire Pain: chg from BL @ wk 72 (n=33,11)	-8.586 Scores on a scale Standard Deviation 22.4850	-3.030 Scores on a scale Standard Deviation 10.0504
Change From Baseline in the EORTC QLQ-C30 Questionnaire Pain: chg from BL @ wk 120 (n=2,0)	0.000 Scores on a scale Standard Deviation 23.5702	—
Change From Baseline in the EORTC QLQ-C30 Questionnaire Dyspnoea: chg from BL @ wk 72 (n=33,11)	-3.030 Scores on a scale Standard Deviation 22.6134	3.030 Scores on a scale Standard Deviation 27.7070
Change From Baseline in the EORTC QLQ-C30 Questionnaire Dyspnoea: chg from BL @ wk 120 (n=2,0)	0.000 Scores on a scale Standard Deviation 0.0000	—
Change From Baseline in the EORTC QLQ-C30 Questionnaire Insomnia: chg from BL @ wk 72 (n=33,11)	0.000 Scores on a scale Standard Deviation 26.3523	6.061 Scores on a scale Standard Deviation 29.1288
Change From Baseline in the EORTC QLQ-C30 Questionnaire Insomnia: chg from BL @ wk 120 (n=2,0)	33.333 Scores on a scale Standard Deviation 47.1405	—
Change From Baseline in the EORTC QLQ-C30 Questionnaire Appetite loss: chg from BL @ wk 72 (n=33,11)	-8.081 Scores on a scale Standard Deviation 20.4639	9.091 Scores on a scale Standard Deviation 21.5557
Change From Baseline in the EORTC QLQ-C30 Questionnaire Appetite loss: chg from BL @ wk 120 (n=2,0)	0.000 Scores on a scale Standard Deviation 0.0000	—
Change From Baseline in the EORTC QLQ-C30 Questionnaire Constipation: chg from BL @ wk 72 (n=33,11)	0.000 Scores on a scale Standard Deviation 18.6339	0.000 Scores on a scale Standard Deviation 14.9071
Change From Baseline in the EORTC QLQ-C30 Questionnaire Constipation: chg from BL @ wk 120 (n=2,0)	0.000 Scores on a scale Standard Deviation 0.0000	—
Change From Baseline in the EORTC QLQ-C30 Questionnaire Diarrhoea: chg from BL @ wk 72 (n=33,11)	-12.121 Scores on a scale Standard Deviation 36.1499	-3.030 Scores on a scale Standard Deviation 27.7070
Change From Baseline in the EORTC QLQ-C30 Questionnaire Diarrhoea: chg from BL @ wk 120 (n=2,0)	-16.667 Scores on a scale Standard Deviation 23.5702	—
Change From Baseline in the EORTC QLQ-C30 Questionnaire Financial difficulties: chg from BL @ wk 72 (n=33,11)	-7.071 Scores on a scale Standard Deviation 33.0798	6.061 Scores on a scale Standard Deviation 20.1008
Change From Baseline in the EORTC QLQ-C30 Questionnaire Financial difficulties: chg from BL @ wk 120 (n=2,0)	-16.667 Scores on a scale Standard Deviation 70.7107	—

SECONDARY outcome

Timeframe: Inclusion (Baseline) (BL), Week 72, Week 120

The Quality of Life GI Neuroendocrine Tumor survey (QLQ GINET21) contains a total of 21 items: four single-item assessments relating to muscle and/or bone pain (MBP), body image (BI), information (INF) and sexual functioning (SX), together with 17 items organized into five proposed scales: endocrine symptoms (ED; three items), GI symptoms (GI; five items), treatment-related symptoms (TR; three items), social functioning (SF) and disease-related worries (DRW; three items). The response format of the questionnaire is a four-point Likert scale. Responses are linearly transformed to a 0-100 scale using EORTC guidelines, with higher scores reflecting more severe symptoms.

Outcome measures

Outcome measures
Measure	177Lu-DOTA0-Tyr3-Octreotate n=112 Participants * 30 mg Octreotide LAR treatment for symptom control continued until the end of study, unless the participant progressed or died. * Treatment consisted of a cumulative administered radioactivity of 29.6 Giga Becquerel (GBq) (800 mCi) 177Lu-DOTA0-Tyr3-Octreotate: Four administrations of 7.4 GBq (200 mCi). * Concomitant amino acids were given with each administration for kidney protection. * 177Lu-DOTA0-Tyr3-Octreotate was administered at 8 +/- 1-week intervals, which could be extended up to 16 weeks to accommodate resolving acute toxicity. * In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, Octreotide s.c. rescue injections were allowed.	Octreotide LAR n=111 Participants * 60 mg Octreotide LAR treatment every 4 weeks (i.m. injections) until the end of the study, unless the participant progressed or died. * In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, s.c. Octreotide rescue injections were allowed.
Change From Baseline in the EORTC Quality of Life Questionnaire - Neuroendocrine Carcinoid Module (EORTC QLQ-GINET21) Endocrine scale: chg from BL @ wk 120 (n=2,0)	0.000 Scores on a scale Standard Deviation 0.0000	—
Change From Baseline in the EORTC Quality of Life Questionnaire - Neuroendocrine Carcinoid Module (EORTC QLQ-GINET21) Social function scale: chg from BL @ wk 72 (n=33,11)	-7.576 Scores on a scale Standard Deviation 23.3985	-7.576 Scores on a scale Standard Deviation 21.1217
Change From Baseline in the EORTC Quality of Life Questionnaire - Neuroendocrine Carcinoid Module (EORTC QLQ-GINET21) Endocrine scale: chg from BL @ wk 72 (n=33,11)	-8.754 Scores on a scale Standard Deviation 20.1762	-11.111 Scores on a scale Standard Deviation 21.0819
Change From Baseline in the EORTC Quality of Life Questionnaire - Neuroendocrine Carcinoid Module (EORTC QLQ-GINET21) G.I. scale: chg from BL @ wk 72 (n=33,11)	-2.727 Scores on a scale Standard Deviation 15.3083	2.424 Scores on a scale Standard Deviation 10.0101
Change From Baseline in the EORTC Quality of Life Questionnaire - Neuroendocrine Carcinoid Module (EORTC QLQ-GINET21) G.I. scale: chg from BL @ wk 120 (n=2,0)	-13.333 Scores on a scale Standard Deviation 0.0000	—
Change From Baseline in the EORTC Quality of Life Questionnaire - Neuroendocrine Carcinoid Module (EORTC QLQ-GINET21) Treatment scale: chg from BL @ wk 72 (n=21,5)	-8.995 Scores on a scale Standard Deviation 14.9563	0.000 Scores on a scale Standard Deviation 11.1111
Change From Baseline in the EORTC Quality of Life Questionnaire - Neuroendocrine Carcinoid Module (EORTC QLQ-GINET21) Treatment scale: chg from BL @ wk 120 (n=1,0)	-16.667 Scores on a scale Standard Deviation NA Only one participant analyzed	—
Change From Baseline in the EORTC Quality of Life Questionnaire - Neuroendocrine Carcinoid Module (EORTC QLQ-GINET21) Social function scale: chg from BL @ wk 120 (n=2,0)	11.111 Scores on a scale Standard Deviation 0.0000	—
Change From Baseline in the EORTC Quality of Life Questionnaire - Neuroendocrine Carcinoid Module (EORTC QLQ-GINET21) Diseases rel. worries scale: chg from BL @ wk 72 (n=33,11)	-6.061 Scores on a scale Standard Deviation 27.9289	1.010 Scores on a scale Standard Deviation 33.7765
Change From Baseline in the EORTC Quality of Life Questionnaire - Neuroendocrine Carcinoid Module (EORTC QLQ-GINET21) Diseases rel. worries scale: chg from BL @ wk 120 (n=2,0)	33.333 Scores on a scale Standard Deviation 31.4270	—
Change From Baseline in the EORTC Quality of Life Questionnaire - Neuroendocrine Carcinoid Module (EORTC QLQ-GINET21) Muscle/Bone pain symptom: chg from BL @ wk 72 (n=33,10)	-5.051 Scores on a scale Standard Deviation 33.4594	-16.667 Scores on a scale Standard Deviation 36.0041
Change From Baseline in the EORTC Quality of Life Questionnaire - Neuroendocrine Carcinoid Module (EORTC QLQ-GINET21) Muscle/Bone pain symptom: chg from BL @ wk 120 (n=2,0)	-16.667 Scores on a scale Standard Deviation 23.5702	—
Change From Baseline in the EORTC Quality of Life Questionnaire - Neuroendocrine Carcinoid Module (EORTC QLQ-GINET21) Sexual function: chg from BL @ wk 72 (n=21,7)	6.349 Scores on a scale Standard Deviation 40.3031	14.286 Scores on a scale Standard Deviation 17.8174
Change From Baseline in the EORTC Quality of Life Questionnaire - Neuroendocrine Carcinoid Module (EORTC QLQ-GINET21) Sexual function: chg from BL @ wk 120 (n=2,0)	50.000 Scores on a scale Standard Deviation 70.7107	—
Change From Baseline in the EORTC Quality of Life Questionnaire - Neuroendocrine Carcinoid Module (EORTC QLQ-GINET21) Information/Communication: chg from BL @ wk 72 (n=33,11)	-4.040 Scores on a scale Standard Deviation 26.0309	-12.121 Scores on a scale Standard Deviation 30.8139
Change From Baseline in the EORTC Quality of Life Questionnaire - Neuroendocrine Carcinoid Module (EORTC QLQ-GINET21) Information/Communication: chg from BL @ wk 120 (n=2,0)	0.000 Scores on a scale Standard Deviation 0.0000	—
Change From Baseline in the EORTC Quality of Life Questionnaire - Neuroendocrine Carcinoid Module (EORTC QLQ-GINET21) Body image: chg from BL @ wk 72 (n=33,11)	-4.040 Scores on a scale Standard Deviation 18.1766	-3.030 Scores on a scale Standard Deviation 17.9787
Change From Baseline in the EORTC Quality of Life Questionnaire - Neuroendocrine Carcinoid Module (EORTC QLQ-GINET21) Body image: chg from BL @ wk 120 (n=2,0)	16.667 Scores on a scale Standard Deviation 23.5702	—

Adverse Events

177Lu-DOTA0-Tyr3-Octreotate

Serious events: 40 serious events

Other events: 105 other events

Deaths: 70 deaths

Octreotide LAR

Serious events: 31 serious events

Other events: 90 other events

Deaths: 68 deaths

Serious adverse events

Other adverse events

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER