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NCT02595424 · OUTCOME

To Assess the Objective Response Rate Based on Marker of Proliferation Ki-67 Index

Cisplatin and Etoposide Versus Temozolomide and Capecitabine in Patients With Advanced Poorly Differentiated (G3) Non-Small Cell Gastrointestinal Neuroendocrine Carcinomas · Source last updated 2026-07-27

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
assessed at baseline, every 8 weeks until treatment completion, then every 3 months within 2 years and every 6 months within 3-5 years, up to 5 years from registration; the best response among all assessments was considered as objective response

What was measured

The impact of each treatment regimen on objective response rate (ORR, defined as above in the secondary objective) are assessed by Ki-67 index level as an exploratory analysis. Using Youden's index, which considers specificity and sensitivity equally important, the optimal cutoff point of Ki-67 index to best predict response is 50.5. Using the optimal Ki-67 cutoff value of 50.5 from the ROC analysis, patients were divided into Ki-67 low (Ki-67 \< 50.5) and high (Ki-67 ≥ 50.5) groups. The impact of each treatment regimen on ORR was explored in Ki-67 low and Ki-67 high separately.

Analysis population: Eligible patients with Ki-67 data

Groups in this outcome

Arm A (Capecitabine, Temozolomide) -- Ki-67 Low

Patients receive capecitabine PO BID on days 1-14 and temozolomide PO QD on days 10-14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Laboratory Biomarker Analysis: Correlative studies Temozolomide: Given PO

Arm B (Cisplatin, Carboplatin, Etoposide)--- Ki-67 Low

Patients receive cisplatin IV on days 1-3 or carboplatin IV on day 1. Patients also receive etoposide IV on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV Etoposide: Given IV Laboratory Biomarker Analysis: Correlative studies

Arm A (Capecitabine, Temozolomide) -- Ki-67 High

Patients receive capecitabine PO BID on days 1-14 and temozolomide PO QD on days 10-14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Laboratory Biomarker Analysis: Correlative studies Temozolomide: Given PO

Arm B (Cisplatin, Carboplatin, Etoposide)--- Ki-67 High

Patients receive cisplatin IV on days 1-3 or carboplatin IV on day 1. Patients also receive etoposide IV on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV Etoposide: Given IV Laboratory Biomarker Analysis: Correlative studie

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Arm A (Capecitabine, Temozolomide) -- Ki-67 Low20
Arm B (Cisplatin, Carboplatin, Etoposide)--- Ki-67 Low14
Arm A (Capecitabine, Temozolomide) -- Ki-67 High11
Arm B (Cisplatin, Carboplatin, Etoposide)--- Ki-67 High18

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A (Capecitabine, Temozolomide) -- Ki-67 Low25.0Not reported8.749.1Not reported
Arm B (Cisplatin, Carboplatin, Etoposide)--- Ki-67 Low35.7Not reported12.864.9Not reported
Arm A (Capecitabine, Temozolomide) -- Ki-67 High9.1Not reported0.241.3Not reported
Arm B (Cisplatin, Carboplatin, Etoposide)--- Ki-67 High27.8Not reported9.753.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.7
        upper Limit
        49.1
        value
        25.0
      2. group Id
        OG001
        lower Limit
        12.8
        upper Limit
        64.9
        value
        35.7
      3. group Id
        OG002
        lower Limit
        0.2
        upper Limit
        41.3
        value
        9.1
      4. group Id
        OG003
        lower Limit
        9.7
        upper Limit
        53.5
        value
        27.8
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    2. group Id
      OG001
      value
      14
    3. group Id
      OG002
      value
      11
    4. group Id
      OG003
      value
      18
    units
    Participants
description
The impact of each treatment regimen on objective response rate (ORR, defined as above in the secondary objective) are assessed by Ki-67 index level as an exploratory analysis. Using Youden's index, which considers specificity and sensitivity equally important, the optimal cutoff point of Ki-67 index to best predict response is 50.5. Using the optimal Ki-67 cutoff value of 50.5 from the ROC analysis, patients were divided into Ki-67 low (Ki-67 \< 50.5) and high (Ki-67 ≥ 50.5) groups. The impact of each treatment regimen on ORR was explored in Ki-67 low and Ki-67 high separately.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive capecitabine PO BID on days 1-14 and temozolomide PO QD on days 10-14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Laboratory Biomarker Analysis: Correlative studies Temozolomide: Given PO
    id
    OG000
    title
    Arm A (Capecitabine, Temozolomide) -- Ki-67 Low
  2. description
    Patients receive cisplatin IV on days 1-3 or carboplatin IV on day 1. Patients also receive etoposide IV on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV Etoposide: Given IV Laboratory Biomarker Analysis: Correlative studies
    id
    OG001
    title
    Arm B (Cisplatin, Carboplatin, Etoposide)--- Ki-67 Low
  3. description
    Patients receive capecitabine PO BID on days 1-14 and temozolomide PO QD on days 10-14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Laboratory Biomarker Analysis: Correlative studies Temozolomide: Given PO
    id
    OG002
    title
    Arm A (Capecitabine, Temozolomide) -- Ki-67 High
  4. description
    Patients receive cisplatin IV on days 1-3 or carboplatin IV on day 1. Patients also receive etoposide IV on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV Etoposide: Given IV Laboratory Biomarker Analysis: Correlative studie
    id
    OG003
    title
    Arm B (Cisplatin, Carboplatin, Etoposide)--- Ki-67 High
param Type
NUMBER
population Description
Eligible patients with Ki-67 data
reporting Status
POSTED
time Frame
assessed at baseline, every 8 weeks until treatment completion, then every 3 months within 2 years and every 6 months within 3-5 years, up to 5 years from registration; the best response among all assessments was considered as objective response
title
To Assess the Objective Response Rate Based on Marker of Proliferation Ki-67 Index
type
OTHER_PRE_SPECIFIED
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice