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Quimioterapia adyuvante para el cáncer de pulmón de células no pequeñas en estadio inicial resecado
Sarah Burdett, Jean Pierre Pignon, Jayne Tierney, Helene Tribodet, Lesley Stewart, Cecile Le Pechoux, Anne Aupérin, Thierry Le Chevalier, Richard J Stephens, Rodrigo Arriagada, Julian PT Higgins, David H Johnson, Jan Van Meerbeeck, Mahesh KB Parmar, Robert L Souhami, Bengt Bergman, Jean‐Yves Douillard, Ariane Dunant, Chiaki Endo, David Girling, Harubumi Kato, Steven M Keller, Hideki Kimura, Aija Knuuttila, Ken Kodama, Ritsuko Komaki, Mark G Kris, Thomas Lad, Tommaso Mineo, Steven Piantadosi, Rafael Rosell, Giorgio Scagliotti, Lesley K Seymour, Frances A Shepherd, Richard Sylvester, Hirohito Tada, Fumihiro Tanaka, Valter Torri, David Waller, Ying Liang, for the Non‐Small Cell Lung Cancer Collaborative Group | 2 marzo 2015

Respuestas clínicas Cochrane

Topics

Temas

Study flow diagram for searches 2008‐2014.
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Figure 1

Study flow diagram for searches 2008‐2014.

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Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
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Figure 2

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

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Forest plot of comparison: 2 Adverse Events, outcome: 2.3 Oesophagitis (grade 3‐4).
Figuras y tablas -
Figure 3

Forest plot of comparison: 2 Adverse Events, outcome: 2.3 Oesophagitis (grade 3‐4).

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Forest plot of comparison: 2 Adverse Events, outcome: 2.1 Radiation Myelopathy (any grade).
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Figure 4

Forest plot of comparison: 2 Adverse Events, outcome: 2.1 Radiation Myelopathy (any grade).

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Forest plot of comparison: 2 Adverse Events, outcome: 2.2 Pneumonitis (any grade).
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Figure 5

Forest plot of comparison: 2 Adverse Events, outcome: 2.2 Pneumonitis (any grade).

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Forest plot of comparison: One year overall survival "more fractionated" vs "less fractionated" regimes, performance status 2‐4. Random effects analysis.
Figuras y tablas -
Figure 6

Forest plot of comparison: One year overall survival "more fractionated" vs "less fractionated" regimes, performance status 2‐4. Random effects analysis.

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Forest plot of comparison: One year overall survival "more fractionated" vs "less fractionated" regimens, performance status 0‐1 ‐ random effects model,
Figuras y tablas -
Figure 7

Forest plot of comparison: One year overall survival "more fractionated" vs "less fractionated" regimens, performance status 0‐1 ‐ random effects model,

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Comparison 1 Adverse Events, Outcome 1 Radiation Myelopathy (any grade).
Figuras y tablas -
Analysis 1.1

Comparison 1 Adverse Events, Outcome 1 Radiation Myelopathy (any grade).

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Comparison 1 Adverse Events, Outcome 2 Pneumonitis (any grade).
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Analysis 1.2

Comparison 1 Adverse Events, Outcome 2 Pneumonitis (any grade).

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Comparison 1 Adverse Events, Outcome 3 Oesophagitis (grade 3‐4).
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Analysis 1.3

Comparison 1 Adverse Events, Outcome 3 Oesophagitis (grade 3‐4).

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Comparison 1 Adverse Events, Outcome 4 Oesophagitis (any grade).
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Analysis 1.4

Comparison 1 Adverse Events, Outcome 4 Oesophagitis (any grade).

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Comparison 2 One year overall survival "more fractionated" vs " less fractionated" regimes ‐ fixed effects analysis, Outcome 1 One year overall survival, performance status 0‐1. Fixed effects analysis.
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Analysis 2.1

Comparison 2 One year overall survival "more fractionated" vs " less fractionated" regimes ‐ fixed effects analysis, Outcome 1 One year overall survival, performance status 0‐1. Fixed effects analysis.

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Comparison 2 One year overall survival "more fractionated" vs " less fractionated" regimes ‐ fixed effects analysis, Outcome 2 One year overall survival, performance status 2‐4. Fixed effects analysis.
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Analysis 2.2

Comparison 2 One year overall survival "more fractionated" vs " less fractionated" regimes ‐ fixed effects analysis, Outcome 2 One year overall survival, performance status 2‐4. Fixed effects analysis.

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Comparison 3 One year overall survival "more fractionated" vs "less fractionated" regimes ‐ random effects analysis, Outcome 1 One year overall survival, performance status 0‐1. Random effects analysis.
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Analysis 3.1

Comparison 3 One year overall survival "more fractionated" vs "less fractionated" regimes ‐ random effects analysis, Outcome 1 One year overall survival, performance status 0‐1. Random effects analysis.

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Comparison 3 One year overall survival "more fractionated" vs "less fractionated" regimes ‐ random effects analysis, Outcome 2 One year overall survival, performance status 2‐4. Random effects analysis.
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Analysis 3.2

Comparison 3 One year overall survival "more fractionated" vs "less fractionated" regimes ‐ random effects analysis, Outcome 2 One year overall survival, performance status 2‐4. Random effects analysis.

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More fractionated thoracic radiotherapy compared with less fractionated radiotherapy for non small cell lung cancer treated with palliative intent

Patient or population: adults with non small cell lung cancer who are not felt to be curable

Settings: specialist oncology units offering external beam radiotherapy

Intervention: More fractionated thoracic radiotherapy

Comparison: Less fractionated radiotherapy

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Fewer fractions

More fractions

1 year overall survival in patients of good performance status (WHO performance status 0‐1)

The mean 1 year overall survival was 25.6% and ranged across control groups from
9.4% to 45.7%

The mean 1 year overall survival in the intervention groups was higher at
33.3%
(11.4% to 46.2%)

1081
(8 studies)

++OO
low

Heterogeneity considered too great for presentation of summary statistic. Not complete data set as unable to get additional data from all authors, high level of heterogeneity

1 year overall survival in patients of poor performance status (WHO performance status 2‐4)

The mean 1 year overall survival was 14.6% and ranged across control groups from
1.3% to 29.5%

The mean 1 year overall survival in the intervention groups was higher at 17.5% (9.1% to 28.6%)

RR 0.96 (0.91 to 1.02)

911
(7 studies)

+++O
moderate

Not complete data set as unable to get additional data from all authors

Oesophagitis (grade 3 to 4)

The mean 22.3% ranged across control groups from 0% to 50%

The mean rate of grade 3‐4 oesophagitis in the intervention groups was higher at 25.7%
(0% to 56%)

RR 1.23 (0.81 to 1.87)

1301 (8 studies)

++OO
low

Not reported in all trials. Some reported as patient reported toxicity others physician assessed toxicity

Radiation Myelopathy (any grade)

The mean 0.30% ranged across control groups from
0% to 1.4%

The mean rate of radiation myelopathy in the intervention groups was higher at 0.38% (0% to 1.61%)

RR 1.29 (0.37 to 4.51)

2663 (11 studies)

+++O
moderate

Reported in most but not all studies. Not graded and most not confirmed at post‐mortem.

Radiation pneumonitis (any grade)

The mean 3.9% ranged across control groups from
2.8% to 6%

The mean rate of radiation pneumonitis in the intervention groups was lower at 2.4% (1.6% to 4%)

RR 0.62 (0.23 to 1.66)

533 (3 studies)

++OO
low

Not reported in the majority of trials and not graded.

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: Confidence interval; RR: Risk Ratio; [other abbreviations, eg. OR, etc]

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

Figuras y tablas -
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Table 1. Radiotherapy regimens and biological effective doses (BED)

RT REGIMEN

STUDY

BED(10): Gy

BED(25): Gy

BED(1.7): Gy

60Gy/39F/6W

Nestle 2000

72

65

131

50Gy/25F/5W

Reinfuss 1999; Sundstrom 2004

60

54

109

45Gy/15/3.5W (4 days per week)

Abratt 1995

59

50

109

45Gy/18F/3.4W

Teo 1988

56

50

111

40GY/10F/4W(split)

Reinfuss 1999; Simpson 1985

56

46

134

42Gy/15F/3W

Sundstrom 2004

54

47

111

39Gy/13F/2.4W

MRC 1996

51

44

108

40Gy/20F/4W

Simpson 1985

48

43

87

36Gy/12F/2.3W

MRC1996

47

40

100

35Gy/10F/2.2W (4 days per week)

Abratt 1995

47

40

107

32Gy/16F/10d (twice daily)

Nestle 2000

38

35

70

31.2Gy/4F/4W (weekly)

Teo 1988

55

41

174

30Gy/10F/2W

MRC 1991, Simpson 1985, Kramer 2005, Erridge 2005

39

34

83

27Gy/6F/2W (3 days per week)

MRC 1991

39

32

98

22.5Gy/5F/5d

Rees 1997

33

27

82

20Gy/5F/5d

Senkus‐Konefka 2005, Bezjak 2002

28

23

67

17Gy/2F/8d (weekly)

MRC 1991, MRC 1992, MRC 1996, Rees 1997, Sundstrom 2004

31

23

102

16Gy/2F/8d (weekly)

Senkus‐Konefka 2005, Kramer 2005

29

21

91

10Gy/1F/1d

MRC 1992, Bezjak 2002, Erridge 2005

20

14

69

BED(y): biologically effective dose (Gy), calculated by the formula: BED(y) = n x d (1+ d/ (alpha/beta)), where n=number of fractions, d= size of each fraction(Gy), and alpha/beta is constant, of value y, for a given tissue type (Fowler 1989, Joiner 1997)

Figuras y tablas -
Table 1. Radiotherapy regimens and biological effective doses (BED)
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Table 2. Survival data (*estimated from published data)

STUDY

RT REGIMEN

Performance Status

Median survival

1‐year survival

2‐year survival

Abratt 1995

45Gy/15F

WHO 0‐2

8.5 months

37%

N/A

Abratt 1995

35Gy/10F

WHO 0‐2

8.5 months

40%

N/A

MRC 1991

30Gy/10F

Any

5.9 months

23%

5%

MRC 1991

17Gy/2F

Any

6.0 months

20%

5%

MRC 1991 (personal correspondence)

30Gy/10F

WHO 0‐1

27.8%

N/A

MRC 1991 (personal correspondence)

30Gy/10F

WHO 2‐4

17.24%

N/A

MRC 1991 (personal correspondence)

17Gy/2F

WHO 0‐1

28.9%

N/A

MRC 1991 (personal correspondence)

17Gy/2F

WHO 2‐4

12.9%

N/A

MRC 1992

17Gy/2F

WHO 2‐4

3.3 months

14%

2%

MRC 1992

10Gy/1F

WHO 2‐4

4.0 months

9%

3%

MRC 1996

17Gy/2F

WHO 0‐2

7 months

31%

12%

MRC 1996

36‐39Gy/12‐13F

WHO 0‐2

9 months

36%

9%

MRC 1996 (personal correspondence)

17Gy/2F

WHO 0‐1

30.7%

N/A

MRC 1996 (personal correspondence)

17Gy/2F

WHO 2

29.5%

N/A

MRC 1996 (personal correspondence)

36‐39Gy/12‐13F

WHO 0‐1

38.4%

N/A

MRC 1996 (personal correspondence)

36‐39Gy/12‐13F

WHO 2

28.3%

N/A

Nestle 2000

32Gy/16F

KPS ≥80

50%

3.1%

Nestle 2000

32Gy/16F

KPS ≥50

8.4 months

36.1%

9%

Nestle 2000

60Gy/30F

KPS ≥80

45.7%

7%

Nestle 2000

60Gy/30F

KPS ≥50

8.3 months

38.1%

9%

Rees 1997

17Gy/2F

Any

6 months*

18%*

5%*

Rees 1997

22.5Gy/5F

Any

6 months*

22%*

12%*

Reinfuss 1999

40Gy/10F (split)

KPS >50

8.3 months

28%

6%

Reinfuss 1999

50Gy/25F

KPS >50

12 months

48%

18%

Simpson 1985

30Gy/10F

KPS >60

6.4 months

22%*

8%*

Simpson 1985

40Gy/20F

KPS >60

6.9 months

30%*

8%*

Simpson 1985

40Gy/20F (split)

KPS >60

6.2 months

30%*

8%*

Sundstrom 2004

17Gy/2F

Any

8.2 months

29%

8%

Sundstrom 2004

42Gy/15F

Any

7 months

29%

13%

Sundstrom 2004

50Gy/25F

Any

6.8 months

31%

10%

Teo 1988

31Gy/4F

Any

5 months

18%*

5%

Teo 1988

45Gy/18F

Any

5 months

22%*

5%

Senkus‐Konefka

20Gy/5F

WHO 1‐4

5.3 months

11%

N/A

Senkus‐Konefka

16Gy/2F

WHO 1‐4

8 months

27%

N/A

Senkus‐Konefka (personal correspondence)

20Gy/5F

WHO 0‐1

12%

N/A

Senkus‐Konefka (personal correspondence)

20Gy/5F

WHO 2‐4

11%

N/A

Senkus‐Konefka (personal correspondence)

16Gy/2F

WHO 0‐1

29%

N/A

Senkus‐Konefka (personal correspondence)

16Gy/2F

WH0 2‐4

25%

N/A

Kramer

16Gy/2F

WHO 3‐4, or stage 4 WHO 0‐2

N/A

10.9%

N/A

Kramer

30Gy/10F

WHO 3‐4, or stage 4 WHO 0‐2

N/A

19.6%

N/A

Kramer (personal correspondence)

30Gy/10F

WHO 0‐1

28.6%

9%

Kramer (personal correspondence)

30Gy/10F

WHO 2‐4

13.4%

0%

Kramer (personal correspondence)

16Gy/2F

WHO 0‐1

7.8%

0%

Kramer (personal correspondence)

16Gy/2F

WHO 2‐4

12.5%

2.3%

Bezjak

10Gy/1F

WHO 0‐3

4.2 months

15%*

N/A

Bezjak

20Gy/5F

WHO 0‐3

6 months

26%*

N/A

Erridge

30Gy/10F

WHO 0‐3

22.7 weeks

28%

8%

Erridge

10Gy/1F

WHO 0‐3

28.3 weeks

19%

4%

Erridge (personal correspondence)

30Gy/10#

WHO 0‐1

31.6%

7.9%

Erridge (personal correspondence)

30Gy/10#

WHO 2‐4

28.1%

9.4%

Erridge (personal correspondence)

10Gy/1#

WHO 0‐1

25.7%

5.7%

Erridge (personal correspondence)

10Gy/1#

WHO 2‐4

14.7%

2.9%
Figuras y tablas -
Table 2. Survival data (*estimated from published data)
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Comparison 1. Adverse Events

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Radiation Myelopathy (any grade) Show forest plot

11

2663

Risk Ratio (M‐H, Fixed, 95% CI)

1.27 [0.39, 4.13]

2 Pneumonitis (any grade) Show forest plot

3

533

Risk Ratio (M‐H, Fixed, 95% CI)

0.61 [0.23, 1.60]

3 Oesophagitis (grade 3‐4) Show forest plot

7

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

4 Oesophagitis (any grade) Show forest plot

10

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only
Figuras y tablas -
Comparison 1. Adverse Events
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Comparison 2. One year overall survival "more fractionated" vs " less fractionated" regimes ‐ fixed effects analysis

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 One year overall survival, performance status 0‐1. Fixed effects analysis Show forest plot

8

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

2 One year overall survival, performance status 2‐4. Fixed effects analysis Show forest plot

7

911

Risk Ratio (M‐H, Fixed, 95% CI)

0.96 [0.91, 1.02]
Figuras y tablas -
Comparison 2. One year overall survival "more fractionated" vs " less fractionated" regimes ‐ fixed effects analysis
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Comparison 3. One year overall survival "more fractionated" vs "less fractionated" regimes ‐ random effects analysis

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 One year overall survival, performance status 0‐1. Random effects analysis Show forest plot

8

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

2 One year overall survival, performance status 2‐4. Random effects analysis Show forest plot

7

911

Risk Ratio (M‐H, Random, 95% CI)

0.97 [0.91, 1.02]
Figuras y tablas -
Comparison 3. One year overall survival "more fractionated" vs "less fractionated" regimes ‐ random effects analysis
Ir a la tabla de la revisión