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Table 5.1GRADE profile: What is the effectiveness of surgery in the primary management of women with ovarian cancer who will receive chemotherapy?

Quality assessmentSummary of findings
Time in monthsEffectQuality
No of studiesDesignLimitationsInconsistencyIndirectnessImprecisionOtherChemotherapy before surgeryChemotherapy after surgeryRelative
(95% CI)
Absolute
Mean OS (P>0.05). Follow-up 32 months (range: 8-98 months) Liu et al., 2004 (in Morrison et al. 2007)
1RCTserious limitations1N/Ano serious indirectnessserious imprecision2N/A33.7
(95%CI: 24.7-42.6)
32.4
(95%CI: 24.9-39.8)
--LOW
Median OS (P>0.05). Follow-up 32 months (range: 8-98 months) Liu et al., 2004 (in Morrison et al. 2007)
1RCTserious limitations1N/Ano serious indirectnessserious imprecision2N/A26
(95%CI: 19.2-32.8)
25
(95%CI: 22.8-27.2)
--LOW
Median DFI (P>0.05). Follow-up 32 months (range: 8-98 months) Liu et al., 2004 (in Morrison et al. 2007)
1RCTserious limitations1N/Ano serious indirectnessserious imprecision2N/A18.2
(no 95%CI)
14.2
(no 95%CI)
--LOW
Overall survival (2= 6.48; P>0.05). Follow-up 32 months (range: 8-98 months) Liu et al., 2004 (in Morrison et al. 2007)
1RCTserious limitations1N/Ano serious indirectnessserious imprecision2N/A----LOW
Quality assessmentSummary of findings
PatientsEffectQuality
No of studiesDesignLimitationsInconsistencyIndirectnessImprecisionOtherInterval debulking surgeryNo interval debulking surgeryRelative
(95% CI)
Absolute
Risk of death (P=0.04) (if surgery was performed by general surgeons). Follow-up 42-48 months. Tangjitgamol et al., 2009
2RCTno serious limitations3no serious inconsistency4no serious indirectnessno serious imprecisionN/A177180RR=0.68
(0.53-0.87)
-HIGH
Risk of death (P=0.9) (if surgery was less extensive or performed by gynaecological surgeons). Follow-up 42-48 months. Tangjitgamol et al., 2009
1RCTno serious limitations3N/Ano serious indirectnessno serious imprecisionN/A216208RR=0.99
(0.79-1.24)
-HIGH
Toxic reactions to chemotherapy (P=0.7). Follow-up 42-48 months. Tangjitgamol et al., 2009
2RCTno serious limitations3no serious inconsistencyno serious indirectnessserious imprecision5N/A7/1776/180RR=1.23
(0.42-3.56)
1 fewer per 100MODERATE
Quality assessmentSummary of findings
PatientsEffectQuality
No of studiesDesignLimitationsInconsistencyIndirectnessImprecisionOther2nd look surgeryWatchful waitingRelative
(95% CI)
Absolute
Overall survival (2=0.74; P=0.39). Follow-up ~70 months. Nicoletto et al., 1997
1RCTserious limitations6N/Ano serious indirectnessserious imprecision7N/A5448HR=0.68
(0.28-1.64)
-LOW
Quality assessmentSummary of findings
PatientsQuality
No of studiesDesignLimitationsInconsistencyIndirectnessImprecisionOther[A] 2nd look surgery then chemotherapy[B] 2nd look surgery then radiotherapy[C] Chemotherapy
Median survival (A vs. B: 9=0.11; P=0.75; A vs. C: 9=0.11; P=0.75). Follow-up 46 months (range: 21-64 months). Luesley et al., 1988
1RCTvery serious limitations8N/Ano serious indirectnessvery serious imprecision9N/A21 months
(95%CI: 11-31 months)
N =42/53
15 months
(95%CI: 11-19 months)
N =49/56
17 months (95%CI: 13-21 months)
N=44/57
VERY LOW
1

This was a non-English language study that had not apparently been translated by the Cochrane reviewers. Although the original study authors stated that they had randomised patients, there were no details of randomisation or allocation and blinding of outcome assessors was not mentioned. Intention to treat (ITT) analysis was used but treatment withdrawals were no discussed.

2

The Kaplan Meier plot and tables accompanying the text of Liu et al., (2004) were not accessible and may have included more data with regard to survival. However this was a low patient number trial. Patients: women with stage III (actually II) or IV EOC; Intervention: neoadjuvant intra-arterial chemo (1 cycle), ovarian artery embolisation then primary surgery followed by adjuvant i.v. chemo (7 cycles) (n=42); Control: primary surgery followed by adjuvant i.v. chemo (8 cycles) (n=43).

3

The three included studies in this systematic review were described by the authors as having given sufficient details of randomisation and allocation but blinding of treatment assessors was not described. All studies used intention to treat (ITT) analysis.

4

The original pooled data for survival from the three included studies showed significant heterogeneity (I2=58%) and the authors addressed this by stratifying data by surgical speciality, as shown in the table.

5

The confidence interval around the estimate of effect spans ‘1’ (the line of no effect) and the limits for ‘appreciable harm’ and ‘appreciable benefit’.

6

This study did not demonstrate adequate details of randomisation, allocation or blinding of treatment assessors. The study used intention to treat (ITT) analyses.

7

The confidence interval is wide and crosses the line of no effect as well as exceeding limits for ‘appreciable harm’ and ‘appreciable benefit’. This is probably due to the low patient number

8

This study did not demonstrate adequate details of randomisation, allocation, blinding of treatment assessors or intention to treat (ITT) analysis.

9

The comparison of Group A vs. Group C may be unsafe since, on the Kaplan Meier plot shown, the lines representing each population cross several times. The statistics (chi square and P value) from Croups A vs. B and A vs. C are identical which may be accurate or not. The study is probably underpowered to detect a significant difference between study arms.

This was a non-English language study that had not apparently been translated by the Cochrane reviewers. Although the original study authors stated that they had randomised patients, there were no details of randomisation or allocation and blinding of outcome assessors was not mentioned. Intention to treat (ITT) analysis was used but treatment withdrawals were no discussed.

The Kaplan Meier plot and tables accompanying the text of Liu et al., (2004) were not accessible and may have included more data with regard to survival. However this was a low patient number trial. Patients: women with stage III (actually II) or IV EOC; Intervention: neoadjuvant intra-arterial chemo (1 cycle), ovarian artery embolisation then primary surgery followed by adjuvant i.v. chemo (7 cycles) (n=42); Control: primary surgery followed by adjuvant i.v. chemo (8 cycles) (n=43).

The three included studies in this systematic review were described by the authors as having given sufficient details of randomisation and allocation but blinding of treatment assessors was not described. All studies used intention to treat (ITT) analysis.

The original pooled data for survival from the three included studies showed significant heterogeneity (I2=58%) and the authors addressed this by stratifying data by surgical speciality, as shown in the table.

The confidence interval around the estimate of effect spans ‘1’ (the line of no effect) and the limits for ‘appreciable harm’ and ‘appreciable benefit’.

This study did not demonstrate adequate details of randomisation, allocation or blinding of treatment assessors. The study used intention to treat (ITT) analyses.

The confidence interval is wide and crosses the line of no effect as well as exceeding limits for ‘appreciable harm’ and ‘appreciable benefit’. This is probably due to the low patient number

This study did not demonstrate adequate details of randomisation, allocation, blinding of treatment assessors or intention to treat (ITT) analysis.

The comparison of Group A vs. Group C may be unsafe since, on the Kaplan Meier plot shown, the lines representing each population cross several times. The statistics (chi square and P value) from Croups A vs. B and A vs. C are identical which may be accurate or not. The study is probably underpowered to detect a significant difference between study arms.

From: 5, Management of advanced (stage II-IV) ovarian cancer

Cover of Ovarian Cancer
Ovarian Cancer: The Recognition and Initial Management of Ovarian Cancer.
NICE Clinical Guidelines, No. 122.
National Collaborating Centre for Cancer (UK).
Copyright © 2011, National Collaborating Centre for Cancer.

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