NCT00686959 · OUTCOME

Survival Rates at 1, 2, and 3 Years

Chemotherapy and Radiation in Treating Participants With Stage 3 Non-Small Cell Lung Cancer · Source last updated 2016-06-28

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

Measure: NUMBER
Unit: probability of survival
Interval / dispersion: 95% Confidence Interval
Time frame: Baseline to Date of Death from Any Cause (Up to 71.4 Months)

What was measured

The probability that survival time is at least 1, 2, or 3 years was summarized using Kaplan-Meier estimates.

Analysis population: All randomized participants. Arm A had 124 participants censored and Arm B had 117 participants censored.

Groups in this outcome

Arm A: Pemetrexed + Cisplatin and TRT

Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT ("Concurrent Phase") for three 21-day cycles, followed by a 3-5 week "Recovery Period," then treated with consolidation chemotherapy with pemetrexed ("Consolidation Phase") for up to four 21-day cycles Concurrent Phase: Pemetrexed: 500 mg/m\^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m\^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions. Consolidation Phase: Pemetrexed: 500 mg/m\^2, IV on Day 1 of each 21-day cycle up to 4 cycles

Arm B: Etoposide + Cisplatin and TRT

Participants were treated with Etoposide plus Cisplatin and concurrent TRT ("Concurrent Phase") for two 28-day cycles, followed by a 3-5 week "Recovery Period," then received consolidation treatment with cytotoxic chemotherapy of choice ("Consolidation Phase") for up to 2 cycles Concurrent Phase: Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m\^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m\^2, IV on Days1, 8, 29, and 36 Consolidation Phase options: Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m\^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m\^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m\^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22

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

Analysis denominator · Participants

Group	Source count
Arm A: Pemetrexed + Cisplatin and TRT	301
Arm B: Etoposide + Cisplatin and TRT	297

Reported measurements

1 year (12 months)

Values in probability of survival · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Arm A: Pemetrexed + Cisplatin and TRT	0.76	Not reported	0.70	0.80	Not reported
Arm B: Etoposide + Cisplatin and TRT	0.77	Not reported	0.72	0.81	Not reported

2 years (24 months)

Values in probability of survival · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Arm A: Pemetrexed + Cisplatin and TRT	0.52	Not reported	0.46	0.58	Not reported
Arm B: Etoposide + Cisplatin and TRT	0.52	Not reported	0.46	0.58	Not reported

3 years (36 months)

Values in probability of survival · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Arm A: Pemetrexed + Cisplatin and TRT	0.40	Not reported	0.34	0.46	Not reported
Arm B: Etoposide + Cisplatin and TRT	0.37	Not reported	0.31	0.43	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
0.70
upper Limit
0.80
value
0.76
group Id
OG001
lower Limit
0.72
upper Limit
0.81
value
0.77
title
1 year (12 months)
categories
measurements
group Id
OG000
lower Limit
0.46
upper Limit
0.58
value
0.52
group Id
OG001
lower Limit
0.46
upper Limit
0.58
value
0.52
title
2 years (24 months)
categories
measurements
group Id
OG000
lower Limit
0.34
upper Limit
0.46
value
0.40
group Id
OG001
lower Limit
0.31
upper Limit
0.43
value
0.37
title
3 years (36 months)

denoms

counts
group Id
OG000
value
301
group Id
OG001
value
297
units
Participants

description

The probability that survival time is at least 1, 2, or 3 years was summarized using Kaplan-Meier estimates.

dispersion Type

95% Confidence Interval

groups

description
Participants were treated with Pemetrexed plus Cisplatin and concurrent TRT ("Concurrent Phase") for three 21-day cycles, followed by a 3-5 week "Recovery Period," then treated with consolidation chemotherapy with pemetrexed ("Consolidation Phase") for up to four 21-day cycles Concurrent Phase: Pemetrexed: 500 mg/m\^2, IV on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m\^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gy per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions. Consolidation Phase: Pemetrexed: 500 mg/m\^2, IV on Day 1 of each 21-day cycle up to 4 cycles
id
OG000
title
Arm A: Pemetrexed + Cisplatin and TRT
description
Participants were treated with Etoposide plus Cisplatin and concurrent TRT ("Concurrent Phase") for two 28-day cycles, followed by a 3-5 week "Recovery Period," then received consolidation treatment with cytotoxic chemotherapy of choice ("Consolidation Phase") for up to 2 cycles Concurrent Phase: Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m\^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m\^2, IV on Days1, 8, 29, and 36 Consolidation Phase options: Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m\^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m\^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m\^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22
id
OG001
title
Arm B: Etoposide + Cisplatin and TRT

param Type

NUMBER

population Description

All randomized participants. Arm A had 124 participants censored and Arm B had 117 participants censored.

reporting Status

POSTED

time Frame

Baseline to Date of Death from Any Cause (Up to 71.4 Months)

title

Survival Rates at 1, 2, and 3 Years

type

SECONDARY

unit Of Measure

probability of survival

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Preserved source evidence · Not medical advice