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Efficacy

Patient-Reported Outcomes (PROs) Across Clinical Trials

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Time to deterioration in patient-reported measures in NETTER-2

Median TTD in Months (95% CI)1,2

Median time to deterioration in month in quality-of-life measures in NETTER-2 according to the EORTC QLQ-C30 subscale. The median time to deterioration in global health status and pain was higher for LUTATHERA compared with SSA (13.2 vs 8.6 months and 10.3 months vs 8.6 months, respectively); the median time to deterioration in diarrhea and fatigue was similar between LUTATHERA and SSA alone (17.4 months vs 17.3 months and 6.0 months vs 6.0 months, respectively).
  • TTD in GHS/QOL was defined as time from randomization to first clinically meaningful deterioration3
  • HRQOL, functioning, and symptoms were assessed using EORTC QLQ-C30 and QLQ-G.I.NET21. EORTC QLQ-C30 is an integrated questionnaire for assessing the HRQOL of cancer patients participating in clinical trials using a scale of 0 to 100, with high scores representing high or healthy levels of functioning/high QOL. The EORTC QLQ-G.I.NET21 was developed as an add-on module to the QLQ-C30 to better assess the symptoms and issues most relevant to patients with neuroendocrine tumors3,4
  • In NETTER-2, 98.7% of patients across arms completed their baseline EORTC QLQ-C30 questionnaire. The compliance rate was above 98% at the first post-baseline assessment and remained ~80% throughout the first year of treatment5
  • QOL was assessed on treatment only and, as of the cutoff date, 80% of patients treated with 60 mg octreotide had discontinued treatment compared with 48% of patients in the LUTATHERA arm5

EORTC, European Organisation for Research and Treatment of Cancer; GHS, global health status; HR, hazard ratio; HRQOL, health-related quality of life; LAR, long-acting release; NE, not evaluable; QLQ-C30, 30-item Quality of Life Questionnaire; QLQ-G.I.NET21, 21-item Gastrointestinal Neuroendocrine Tumor Quality of Life Questionnaire; QOL, quality of life; TTD, time to deterioration.

Patient-reported symptom-free days from NETTER-1

Mean Change From Baseline in Number of Days With Symptoms per 4-Week Period6,a

Patients reported more symptom-free days per 4-week period with LUTATHERA in NETTER-1, including symptoms of abdominal pain (~3 more symptom-free days vs control), diarrhea (~3 more symptom-free days vs control), and flushing (~2 more symptom-free days vs control).

aAnalysis of patient-reported daily symptom diaries from NETTER-1.6

Study analysis6

  • All patients enrolled in the NETTER-1 trial were asked to record the presence or absence (in the preceding 24 hours) of 18 predefined symptoms in a paper-based, daily diary

  • A "symptom score" was defined as the number of days with each symptom within the 4-week period between clinic visits during treatment

  • The change from baseline in the mean number of days with symptoms was assessed using a mixed model for repeated measures, adjusting for baseline symptom status, time from randomization, treatment, and the interaction between time from randomization and treatment

  • Shown above are the 3 symptoms considered most clinically relevant to patients with midgut NETs, namely abdominal pain, diarrhea, and flushing

Patient symptom diaries data

  • Data from the patient symptom diaries should be interpreted with caution

  • Patient symptom diaries are a nonvalidated instrument collected per protocol in NETTER-1; analysis methods for symptom scores were not prespecified; patients were unable to be blinded to treatment due to the open-label nature of the trial; and n values decreased over time6,7

  • Patient symptom diaries data are not included in the Prescribing Information for LUTATHERA

NETs, neuroendocrine tumors.

References: 1. Singh S, Halperin D, Myrehaug S, et al. [177Lu]Lu-DOTA-TATE plus long-acting octreotide versus high-dose long-acting octreotide for the treatment of newly diagnosed, advanced grade 2-3, well-differentiated, gastroenteropancreatic neuroendocrine tumours (NETTER-2): an open-label, randomised, phase 3 study. Lancet. 2024;403(10446):2807-2817. 2. Singh S, Halperin D, Myrehaug S, et al. [177Lu]Lu-DOTA-TATE plus long-acting octreotide versus high-dose long-acting octreotide for the treatment of newly diagnosed, advanced grade 2-3, well-differentiated, gastroenteropancreatic neuroendocrine tumours (NETTER-2): an open-label, randomised, phase 3 study. Lancet. 2024;403(10446)(suppl):2807-2817. 3. Data on file. Novartis Pharmaceuticals Corp; 2021. 4. Benavent M, Sastre J, Escobar IG, et al. Physician-perceived utility of the EORTC QLQ-GINET21 questionnaire in the treatment of patients with gastrointestinal neuroendocrine tumours: a multicentre, cross-sectional survey (QUALINETS). Health Qual Life Outcomes. 2021;19(1):38. 5. Data on file. CAAA601A22301 Clinical Study Report. Novartis Pharmaceuticals Corp; 2024. 6. Strosberg JR, Srirajaskanthan R, El-Haddad G, et al. Symptom diaries of patients with midgut neuroendocrine tumors treated with 177Lu-DOTATATE. J Nucl Med. 2021;62(12):1712-1718. 7. Strosberg J, El-Haddad G, Wolin E, et al; for the NETTER-1 trial investigators. Phase 3 trial of 177Lu-dotatate for midgut neuroendocrine tumors. N Engl J Med. 2017;376(2)(suppl):125-135.