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Cochrane Database of Systematic Reviews

Autologous hematopoietic stem cell transplantation following high‐dose chemotherapy for nonrhabdomyosarcoma soft tissue sarcomas

Information

DOI:
https://doi.org/10.1002/14651858.CD008216.pub5Copy DOI
Database:
  1. Cochrane Database of Systematic Reviews
Version published:
  1. 13 April 2017see what's new
Type:
  1. Intervention
Stage:
  1. Review
Cochrane Editorial Group:
  1. Cochrane Gynaecological, Neuro-oncology and Orphan Cancer Group

Copyright:
  1. Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Authors

  • Frank Peinemann

    Correspondence to: Pediatric Oncology and Hematology, Children's Hospital, University of Cologne, Cologne, Germany

    [email protected]

  • Heike Enk

    c/o Cochrane Childhood Cancer, Amsterdam, Netherlands

  • Lesley A Smith

    Department of Psychology, Social Work and Public Health, Oxford Brookes University, Oxford, UK

Contributions of authors

FP: designed and co‐ordinated the review, collected data, designed search strategies, undertook searches, screened search results, organized retrieval of papers, screened retrieved papers against eligibility criteria, appraised quality of papers, extracted data from papers, wrote to authors of papers for additional information, managed data, entered data into Review Manager 5, analyzed data, interpreted data, wrote manuscript.

HE: screened retrieved papers against eligibility criteria, reviewed manuscript.

LAS: provided methodologic advice, appraised quality of papers, reviewed manuscript.

Sources of support

Internal sources

  • University of Cologne, Germany.

    Provision of full texts

External sources

  • No sources of support supplied

Declarations of interest

FP: none known.

HE: none known.

LAS: none known.

Acknowledgements

We thank the Cochrane Gynaecological, Neuro‐oncology and Orphan Cancers Editorial Team for their assistance during the preparation of the review.

This project was supported by the National Institute for Health Research, via Cochrane Infrastructure funding to the Cochrane Gynaecological, Neuro‐oncology and Orphan Cancer Group. The views and opinions expressed therein are those of the review authors and do not necessarily reflect those of the Systematic Reviews Programme, NIHR, National Health Service, or the Department of Health.

Version history

Published

Title

Stage

Authors

Version

2017 Apr 13

Autologous hematopoietic stem cell transplantation following high‐dose chemotherapy for nonrhabdomyosarcoma soft tissue sarcomas

Review

Frank Peinemann, Heike Enk, Lesley A Smith

https://doi.org/10.1002/14651858.CD008216.pub5

2013 Aug 07

Autologous hematopoietic stem cell transplantation following high dose chemotherapy for non‐rhabdomyosarcoma soft tissue sarcomas

Review

Frank Peinemann, Lesley A Smith, Carmen Bartel

https://doi.org/10.1002/14651858.CD008216.pub4

2011 Feb 16

Autologous hematopoietic stem cell transplantation following high‐dose chemotherapy for non‐rhabdomyosarcoma soft tissue sarcomas

Review

Frank Peinemann, Lesley A Smith, Mandy Kromp, Carmen Bartel, Nicolaus Kröger, Michael Kulig

https://doi.org/10.1002/14651858.CD008216.pub3

2010 Feb 17

Autologous stem cell transplantation following high‐dose chemotherapy for non‐rhabdomyosarcoma soft tissue sarcomas

Protocol

Frank Peinemann, Annegret Herrmann‐Frank, Mandy Hildebrandt, Carmen Bartel, Tatjana Burkhardt‐Hammer, Robert Grosselfinger, Michael Kulig, Nicolaus Kröger, Stefan Lange

https://doi.org/10.1002/14651858.CD008216.pub2

2010 Jan 20

Autologous stem cell transplantation following high‐dose chemotherapy for non‐rhabdomyosarcoma soft tissue sarcomas

Protocol

Frank Peinemann, Carmen Bartel, Mandy Hildebrandt, Michael Kulig, Tatjana Burkhardt‐Hammer, Nicolaus Kröger, Stefan Lange

https://doi.org/10.1002/14651858.CD008216

Differences between protocol and review

Differences between the previous version and the current version of the review

We revised the criteria for considering studies for this review. First, we confined the types of studies to RCTs. Therefore, we removed non‐randomized studies and associated data from the review. The single RCT included in the previous version was carried over to the current version of the review. Second, we extended the previous WHO classification of soft tissue sarcomas by adding information from the recently updated version of the WHO classification of soft tissue sarcomas. We revised the search strategies to improve precision and reported the results of the update search.

We changed the items of the 'Risk of bias' tool. We removed the items that were designed to judge the risk of bias of non‐randomized studies. We extended the rest of the items to complete all items of the risk of bias for RCTs. Thus, we included the judgment of some items of risk of bias that were not part of the previous version. Subsequently, the risk of bias was different between the previous and the current version of the review and the judgment changed from low to unclear risk of bias.

We identified additional inconsistencies in the reporting of the included study and sent inquiries to two authors of that study, but we did not receive a response. We identified a published warning letter sent by the FDA to the first author. We do not know if the cause of this letter was associated with conducting the study.

Keywords

MeSH

PICOs

Population
Intervention
Comparison
Outcome

The PICO model is widely used and taught in evidence-based health care as a strategy for formulating questions and search strategies and for characterizing clinical studies or meta-analyses. PICO stands for four different potential components of a clinical question: Patient, Population or Problem; Intervention; Comparison; Outcome.

See more on using PICO in the Cochrane Handbook.

Study flow diagram.
Figures and Tables -
Figure 1

Study flow diagram.

Risk of bias graph: review authors' judgments about each risk of bias item presented as percentages across all included studies.
Figures and Tables -
Figure 2

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

Summary of findings for the main comparison. Autologous hematopoietic stem cell transplantation following high‐dose chemotherapy for nonrhabdomyosarcoma soft tissue sarcoma

Autologous hematopoietic stem cell transplantation following high‐dose chemotherapy for nonrhabdomyosarcoma soft tissue sarcoma

Patient or population: people with non‐rhabdomyosarcoma soft tissue sarcoma

Settings: specialized hospital

Intervention: autologous hematopoietic stem cell transplantation following HDCT

Comparison: SDCT

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

SDCT

Autologous HSCT following HDCT

Overall survival

Follow‐up: median 55 months

489 per 1000

571 per 1000
(375 to 785)

HR 1.26
(0.7 to 2.29)

83
(1 study)

⊕⊕⊕⊕
High

Treatment‐related mortality

Follow‐up: 24 months

See comment

See comment

Not estimable

83
(1 study)

⊕⊕⊕⊕
High

1 event 2 years after HDCT and 0 events after SDCT

Disease‐free survival
Follow‐up: 3 years

See comment

See comment

Not estimable

See comment

Not reported

Progression‐free survival

Follow‐up: median 55 months

756 per 1000

849 per 1000
(681 to 955)

HR 1.34
(0.81 to 2.2)

83
(1 study)

⊕⊕⊕⊕
High

Non‐hematologic toxicity grade 3 to 4

See comment

See comment

Not estimable

See comment

Not adequately reported, people from within and without the randomization were mixed in the control arm.

Health‐related quality of life

See comment

See comment

Not estimable

See comment

Not reported

*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; HDCT: high‐dose chemotherapy; HR: hazard ratio; HSCT: hematopoietic stem cell transplantation; SDCT: standard‐dose chemotherapy.

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.

Figures and Tables -
Summary of findings for the main comparison. Autologous hematopoietic stem cell transplantation following high‐dose chemotherapy for nonrhabdomyosarcoma soft tissue sarcoma
Table 1. Tumor entities reported by Bui‐Nguyen 2012

Sarcoma type

Sarcoma type 'Others'

Both arms

HDCT arm

SDCT arm

Leiomyosarcoma

16

7

9

Liposarcoma

10

6

4

Synovial sarcoma

9

2

7

Angiosarcoma

6

2

4

Malignant peripheral nerve sheath tumor

2

1

1

Clear cell sarcoma

1

1

0

Desmoplastic small round cell sarcoma

1

0

1

Rhabdomyosarcoma

9

4

5

Malignant fibrous histiocytoma

16

8

8

Extraskeletal osteosarcoma

1

0

1

Melanoma*

1

1

0

'Others'

Leiomyosarcoma

1

1

0

Fibrosarcoma

1

1

0

Myofibrosarcoma

1

0

1

Undifferentiated sarcoma

2

1

1

Desmoplastic small round cell sarcoma

2

2

0

Gastrointestinal stromal tumor

1

0

1

Malignant Triton tumor

1

0

1

Unclassified sarcoma

1

1

0

Myoepithelioma*

2

2

0

Endometrial stromal sarcoma*

3

1

2

Total

87

41

46

Not listed in the WHO classification

6

4

2

HDCT: high‐dose chemotherapy; SDCT: standard‐dose chemotherapy; WHO: World Health Organization.

Bui‐Nguyen: the table lists the sarcoma types assigned to each individual of all randomized participants of the study by Bui‐Nguyen 2012.

*Soft tissue sarcomas: tumor entities not listed in either versions of the WHO classification (Fletcher 2002; Fletcher 2013), or soft tissue tumors not categorized as malignant are italicized. Myoepithelioma is categorized as an intermediate soft tissue tumor. Melanoma and endometrial stromal sarcoma are not listed in the classification.

Figures and Tables -
Table 1. Tumor entities reported by Bui‐Nguyen 2012