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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

Topics

Temas

Study flow diagram.
Figuras y tablas -
Figure 1

Study flow diagram.

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Risk of bias summary: review authors' judgements about each 'Risk of bias' item for each included study (the judgement for performance and detection bias is for endpoints other than overall survival).
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Figure 2

Risk of bias summary: review authors' judgements about each 'Risk of bias' item for each included study (the judgement for performance and detection bias is for endpoints other than overall survival).

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Risk of bias graph: review authors' judgements about each 'Risk of bias' item presented as percentages across all included studies (the judgement for performance and detection bias is for endpoints other than overall survival).
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Figure 3

Risk of bias graph: review authors' judgements about each 'Risk of bias' item presented as percentages across all included studies (the judgement for performance and detection bias is for endpoints other than overall survival).

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Combined EPP plus neoadjuvant platinum‐based chemotherapy plus post operative high‐dose hemithoracic radiotherapy compared with combined EPP plus neoadjuvant platinum‐based chemotherapy for malignant pleural mesothelioma

Patient or population: people with malignant pleural mesothelioma

Settings: specialist hospital

Intervention: combined EPP plus neoadjuvant platinum‐based chemotherapy plus postoperative high‐dose hemithoracic radiotherapy

Comparison: combined EPP plus neoadjuvant platinum‐based chemotherapy

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

combined EPP plus chemotherapy

combined EPP plus chemotherapy plus hemithoracic radiotherapy

Median overall survival

20.8 months (95% CI 14.4 to 27.8)

19.3 months (95% CI 11.5 to 21.8)

‐

54 (1)

⊕⊕⊕⊝

Moderate1

Health‐related health‐related quality of life

No changes in the scores for the overall evaluation of life in both groups up to week 14 after randomisation

‐

54 (1)

⊕⊕⊝⊝

Low2

Adverse events

The following adverse events were observed in the radiotherapy arm: anaemia (74%), nausea or vomiting (44%), oesophagitis (29%), fatigue (24%), weight loss (19%), dyspnoea (4%), diarrhoea (4%), and increased alkaline phosphatase concentration (4%).

There was no comment on the adverse events in the no radiotherapy arm.

‐

54 (1)

⊕⊕⊝⊝

Low2

Postoperative complications

Postoperative complications included mediastinal shift (11%), major infections (8%), bleeding (6%), bronchial stump fistula(3%), pulmonary embolism, chylothorax, and technical failures (2% each). It was not classified in the trial based on treatment arms

‐

54 (1)

⊕⊕⊝⊝

Low2

Treatment‐related death

None reported.

One patient died of a complicated pneumonia during radiotherapy, which was probably related to treatment.

‐

54 (1)

⊕⊕⊝⊝

Low2

*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; EPP: extrapleural pneumonectomy.

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.

1Due to imprecision, the quality of the evidence was assessed as moderate.

2Due to imprecision as well as high risk of bias, the quality of the evidence was assessed as low.

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Combined platinum‐based chemotherapy plus EPP plus postoperative hemithoracic radiotherapy compared with chemotherapy for malignant pleural mesothelioma

Patient or population: people with malignant pleural mesothelioma

Settings: specialist hospital

Intervention: combined chemotherapy plus EPP plus postoperative hemithoracic radiotherapy

Comparison: chemotherapy

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Chemotherapy

Combined chemotherapy plus EPP plus postoperative hemithoracic radiotherapy

Median overall survival

19.5 months (95% CI 13.4 to time‐not‐yet reached)

14.4 months (95% CI 5.3 to 18.7)

‐

50 (1)

⊕⊕⊕⊝

Moderate

1

Health‐related health‐related quality of life

There were no statistically significant differences between treatment groups

‐

50 (1)

⊕⊕⊝⊝

Low2

Adverse events

2 serious adverse events

10 serious adverse events

‐

50 (1)

⊕⊕⊝⊝

Low2

Progression‐free survival

9.0 months (95% CI 7.2 to 14.7)

7.6 months (95% CI 5.0 to 13.4)

‐

50 (1)

⊕⊕⊝⊝

Low2

Treatment‐related death

One perioperative death occurred in the no EPP group (because one of the patients underwent EPP surgery outside the trial).

Three perioperative deaths occurred in patients randomly assigned to EPP.

‐

50 (1)

⊕⊕⊝⊝

Low2

*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; EPP: extrapleural pneumonectomy

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.

1Due to imprecision, the quality of the evidence was assessed as moderate.

2Due to imprecision as well as high risk of bias, the quality of the evidence was assessed as low.

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