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Study flow diagram.
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Figure 1

Study flow diagram.

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Forest plot of comparison: 1 Survival, outcome: 1.1 Progression‐free survival.
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Figure 2

Forest plot of comparison: 1 Survival, outcome: 1.1 Progression‐free survival.

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Forest plot of comparison: 1 Survival, outcome: 1.2 Overall survival.
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Figure 3

Forest plot of comparison: 1 Survival, outcome: 1.2 Overall survival.

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Forest plot of comparison: 2 Failure after treatment, outcome: 2.1 Total failure after treatment.
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Figure 4

Forest plot of comparison: 2 Failure after treatment, outcome: 2.1 Total failure after treatment.

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Forest plot of comparison: 2 Failure after treatment, outcome: 2.2 Local failure.
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Figure 5

Forest plot of comparison: 2 Failure after treatment, outcome: 2.2 Local failure.

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Forest plot of comparison: 2 Failure after treatment, outcome: 2.3 Distant failure.
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Figure 6

Forest plot of comparison: 2 Failure after treatment, outcome: 2.3 Distant failure.

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Forest plot of comparison: 3 Adverse events, outcome: 3.1 Anaemia.
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Figure 7

Forest plot of comparison: 3 Adverse events, outcome: 3.1 Anaemia.

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Forest plot of comparison: 3 Adverse events, outcome: 3.2 Thrombocytopenia.
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Figure 8

Forest plot of comparison: 3 Adverse events, outcome: 3.2 Thrombocytopenia.

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Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
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Figure 9

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
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Figure 10

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Comparison 1 Survival, Outcome 1 Progression‐free survival.
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Analysis 1.1

Comparison 1 Survival, Outcome 1 Progression‐free survival.

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Comparison 1 Survival, Outcome 2 Overall survival.
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Analysis 1.2

Comparison 1 Survival, Outcome 2 Overall survival.

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Comparison 2 Failure after treatment, Outcome 1 Total failure after treatment.
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Analysis 2.1

Comparison 2 Failure after treatment, Outcome 1 Total failure after treatment.

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Comparison 2 Failure after treatment, Outcome 2 Local failure.
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Analysis 2.2

Comparison 2 Failure after treatment, Outcome 2 Local failure.

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Comparison 2 Failure after treatment, Outcome 3 Distant failure.
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Analysis 2.3

Comparison 2 Failure after treatment, Outcome 3 Distant failure.

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Comparison 3 Adverse events, Outcome 1 Anaemia.
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Analysis 3.1

Comparison 3 Adverse events, Outcome 1 Anaemia.

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Comparison 3 Adverse events, Outcome 2 Thrombocytopenia.
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Analysis 3.2

Comparison 3 Adverse events, Outcome 2 Thrombocytopenia.

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Table 1. Survival outcome

Study

Lordvithaya

Dueñas‐Gonzalez

N (CCRT versus CCRT/ACT)

233 versus 230

256 versus 259

FU

89 months

46.9 months

Outcomes (CCRT versus CCRT/ACT)

 

 

1.        OS

 

 

·         3‐year OS

85% versus 79% (estimated from graph), P value NS

HR 1.309, 95% CI 0.795 to 2.157 (by Parmar method)

69% versus 78% (estimated from graph)

HR 0.68, 95% CI 0.49 to 0.95, P value 0.0224

·         5‐year OS        

82.7% (79.0 to 86.4) versus 73.6 (67.1 to 80.1), P value NS

‐

2.        PFS

 

 

·         3‐year PFS

68% versus 63% (estimated from graph), P value NS

HR 1.125, 95% CI 0.799 to 1.586 (by Parmar method)

65.0% (58.5 to 70.7) versus 74.4 % (68 to 79.8)

HR 0.68, 95% CI 0.49 to 0.95), P value 0.0227

·         5‐year PFS

64.5% (60.6 to 68.0) versus 59.7% (53.6 to 65.8), P value NS

‐
Figuras y tablas -
Table 1. Survival outcome
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Table 2. Recurrence

Study

Lordvithaya

Dueñas‐Gonzalez

N (CCRT versus CCRT/ ACT)

233 versus 230

256 versus 259

·         Local (with or without DR)

31 (14.3%) versus 36 (17.6%), P value NS

16.4% versus 11.2%, P value 0.097

·         Distant (with or without LR)

38 (17.7%) versus 40 (19.5%), P value NS

16.4% versus 8.1%, P value 0.005

·         Local and/ or distant

63 (29.0%) versus 64 (31.2%), P value NS

 ‐
Figuras y tablas -
Table 2. Recurrence
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Table 3. Response rate

Study

Lordvithaya

Dueñas‐Gonzalez

Response rate

NA

93.4 (89.6 to 96.1) in CCRT arm versus 95.8 (92.5 to 97.9) in CCRT + ACT arm, P value 0.249

Figuras y tablas -
Table 3. Response rate
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Table 4. Acute adverse event

Adverse events/Study

Lordvithaya

n (%)

Dueñas‐Gonzalez

n (%)

CCRT

(N = 218)

CCRT + ACT

(N = 211)

CCRT

(N = 255)

CCRT + ACT

(N = 260)

Acute adverse event (grade 1 to 2)

1. Haematological

  • Leucopenia

110 (50.4)

139 (65.8)

NA

  • Anaemia

137 (62.8)

142 (67.3)

86 (33.8)

128 (49.3)

  • Neutropenia

NA

62 (24.3)

80 (30.8)

  • Febrile neutropenia

NA

0

1 (0.4)

  • Thrombocytopenia

56 (25.7)

70 (33.5)

26 (10.2)

58 (32.4)

  • Haemorrhage

NA

NA

2. Gastrointestinal

  • Nausea

NA

148 (58.0)

153 (58.8)

  • Vomiting

NA

116 (45.5)

129 (49.6)

  • Anorexia

NA

37 (14.5)

46 (17.7)

  • Diarrhoea

NA

119 (46.7)

121 (46.5)

  • Liver

NA

6 (1.6)

33 (12.6)

  • Proctitis

NA

20 (7.9)

29 (11.2)

3. Genitourinary (increased Cr level)

NA

2 (0.8)

5 (1.9)

4. Skin

NA

40 (15.7)

45 (17.3)

5. Neurological

NA

NA

6. Pulmonary

NA

NA

Acute adverse event (grade 3 to 4)

1. Haematological

  • Leucopenia

9 (4.1)

6 (2.9)

NA

  • Anaemia

0

5 (2.0)

24 (9.2)

  • Neutropenia

NA

15 (5.9)

133 (51.2)

  • Febrile neutropenia

NA

1 (0.4)

6 (2.3)

  • Thrombocytopenia

5 (2.3)

3 (1.5)

3 (1.2)

16 (6.2)

  • Haemorrhage

NA

NA

2. Gastrointestinal

  • Nausea

NA

7 (2.7)

11 (4.2)

  • Vomiting

NA

7 (2.8)

20 (7.7)

  • Anorexia

NA

0

1 (0.4)

  • Diarrhoea

NA

12 (4.7)

46 (17.7)

  • Liver

NA

0

4 (1.6)

  • proctitis

NA

1 (0.4)

9 (3.5)

3. Genitourinary (increased Cr level)

NA

2 (0.8)

4 (1.5)

4. Skin

NA

27 (10.6)

29 (11.2)

5. Neurological

NA

NA

6. Pulmonary

NA

NA
Figuras y tablas -
Table 4. Acute adverse event
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Table 5. Late adverse event

Study

Lordvithaya

n (%)

Dueñas‐Gonzalez

n (%)

Late adverse event (grade 3 to 4)

1. Bowel

3.1% vs 5.8%

1 (0.5) vs 5 (2.3)

2. Bladder

1 (0.5) vs 3 (1.4)

3. Mucous membrane

NA

1 (0.5%) vs 1 (0.5)

4. Subcutaneous

0 vs 1 (0.5)
Figuras y tablas -
Table 5. Late adverse event
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Comparison 1. Survival

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Progression‐free survival Show forest plot

2

Hazard Ratio (Fixed, 95% CI)

Totals not selected

2 Overall survival Show forest plot

2

Hazard Ratio (Fixed, 95% CI)

Totals not selected
Figuras y tablas -
Comparison 1. Survival
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Comparison 2. Failure after treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Total failure after treatment Show forest plot

2

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

2 Local failure Show forest plot

2

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

3 Distant failure Show forest plot

2

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected
Figuras y tablas -
Comparison 2. Failure after treatment
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Comparison 3. Adverse events

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Anaemia Show forest plot

2

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

2 Thrombocytopenia Show forest plot

2

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected
Figuras y tablas -
Comparison 3. Adverse events
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