The lessons of QUANTEC: recommendations for reporting and gathering data on dose-volume dependencies of treatment outcome.

The 16 clinical articles in this issue review the dose-volume dependence of toxicities of external beam radiotherapy. They are limited by the difficulty of synthesizing results from different publications. The major problems stem from incomplete reporting of results and use of incompatible or ambiguous endpoints. Here we specify these problems; give recommendations to authors, editors, and reviewers on standards of reporting; and provide methods of defining endpoints suitable for the dose-volume analysis of toxicity. Adopting these recommendations will facilitate meta-analysis and increase the utility of individual studies of the dependence of complications on dose distributions.

[1]  D P Dearnaley,et al.  Correlations between dose-surface histograms and the incidence of long-term rectal bleeding following conformal or conventional radiotherapy treatment of prostate cancer. , 2001, International journal of radiation oncology, biology, physics.

[2]  Andrew Jackson,et al.  The atlas of complication incidence: a proposal for a new standard for reporting the results of radiotherapy protocols. , 2006, Seminars in radiation oncology.

[3]  C. Ling,et al.  Late rectal toxicity after conformal radiotherapy of prostate cancer (I): multivariate analysis and dose-response. , 2000, International journal of radiation oncology, biology, physics.

[4]  L. J. Wei,et al.  Testing Goodness of Fit for Proportional Hazards Model with Censored Observations , 1984 .

[5]  J. Deasy,et al.  Modeling radiation pneumonitis risk with clinical, dosimetric, and spatial parameters. , 2006, International journal of radiation oncology, biology, physics.

[6]  R. Mohan,et al.  Dose-volume modeling of the risk of postoperative pulmonary complications among esophageal cancer patients treated with concurrent chemoradiotherapy followed by surgery. , 2006, International journal of radiation oncology, biology, physics.

[7]  C. Ling,et al.  Risk group dependence of dose-response for biopsy outcome after three-dimensional conformal radiation therapy of prostate cancer. , 2002, Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology.

[8]  R K Ten Haken,et al.  Dose, volume, and function relationships in parotid salivary glands following conformal and intensity-modulated irradiation of head and neck cancer. , 1999, International journal of radiation oncology, biology, physics.

[9]  H. Joensuu,et al.  Erratum to "Sparing of the submandibular glands by intensity modulated radiotherapy in the treatment of head and neck cancer" [Radiother. Oncol. 78 (2006) 270-275]. , 2006, Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology.

[10]  G J Kutcher,et al.  Analysis of clinical complication data for radiation hepatitis using a parallel architecture model. , 1995, International journal of radiation oncology, biology, physics.

[11]  A Pollack,et al.  Complications from radiotherapy dose escalation in prostate cancer: preliminary results of a randomized trial. , 2000, International journal of radiation oncology, biology, physics.

[12]  Radhe Mohan,et al.  Analysis of radiation pneumonitis risk using a generalized Lyman model. , 2008, International journal of radiation oncology, biology, physics.

[13]  A Jackson,et al.  Partial irradiation of the rectum. , 2001, Seminars in radiation oncology.

[14]  C. Reddy,et al.  Dose/Volume Relationship of Late Rectal Bleeding After External Beam Radiotherapy for Localized Prostate Cancer: Absolute or Relative Rectal Volume? , 2001, Cancer journal.

[15]  P. Rubin,et al.  EORTC Late Effects Working Group. Overview of late effects normal tissues (LENT) scoring system. , 1995, Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology.

[16]  H. Bartelink,et al.  Correction for the use of the SOMA LENT tables. , 1996, International journal of radiation oncology, biology, physics.

[17]  J. Deasy,et al.  A prospective study of salivary function sparing in patients with head-and-neck cancers receiving intensity-modulated or three-dimensional radiation therapy: initial results. , 2001, International journal of radiation oncology, biology, physics.

[18]  C. Ling,et al.  Abstract226: EUD and Dose-Volume Based Atlases of Complication Incidence: A Proposal for New Standards in Reporting Results of Treatment Protocols , 2006 .

[19]  H. Bartelink,et al.  EORTC Late Effects Working Group. Late effects toxicity scoring: the SOMA scale. , 1995, Radiotherapy and Oncology.

[20]  Joseph O Deasy,et al.  Dose-volume modeling of salivary function in patients with head-and-neck cancer receiving radiotherapy. , 2005, International journal of radiation oncology, biology, physics.

[21]  David A. Schoenfeld,et al.  Chi-squared goodness-of-fit tests for the proportional hazards regression model , 1980 .

[22]  Randall K Ten Haken,et al.  Final toxicity results of a radiation-dose escalation study in patients with non-small-cell lung cancer (NSCLC): predictors for radiation pneumonitis and fibrosis. , 2006, International journal of radiation oncology, biology, physics.

[23]  S. Bentzen Towards evidence based radiation oncology: improving the design, analysis, and reporting of clinical outcome studies in radiotherapy. , 1998, Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology.

[24]  Joseph O Deasy,et al.  A nomogram to predict radiation pneumonitis, derived from a combined analysis of RTOG 9311 and institutional data. , 2007, International journal of radiation oncology, biology, physics.

[25]  P. Koper,et al.  Localized volume effects for late rectal and anal toxicity after radiotherapy for prostate cancer. , 2005, International journal of radiation oncology, biology, physics.

[26]  G J Kutcher,et al.  Late rectal bleeding after conformal radiotherapy of prostate cancer. II. Volume effects and dose-volume histograms. , 2001, International journal of radiation oncology, biology, physics.

[27]  Joos V Lebesque,et al.  Gastrointestinal toxicity and its relation to dose distributions in the anorectal region of prostate cancer patients treated with radiotherapy. , 2005, International journal of radiation oncology, biology, physics.

[28]  Sunho Lee,et al.  Comparison of goodness of fit tests for the cox proportional hazards model , 2000 .

[29]  Heikki Joensuu,et al.  Sparing of the submandibular glands by intensity modulated radiotherapy in the treatment of head and neck cancer. , 2006, Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology.

[30]  Jacques Bernier,et al.  Late effects toxicity scoring: the SOMA scale , 1995 .

[31]  F. García-Vicente,et al.  Statistical analysis of dose-volume and dose-wall histograms for rectal toxicity following 3D-CRT in prostate cancer. , 2005, Medical physics.

[32]  R K Ten Haken,et al.  Partial irradiation of the parotid gland. , 2001, Seminars in Radiation Oncology.

[33]  T. Schultheiss Spinal cord radiation tolerance. , 1994, International journal of radiation oncology, biology, physics.

[34]  S. Bentzen,et al.  The need for adverse effects reporting standards in oncology clinical trials. , 2004, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[35]  P. Rubin,et al.  RTOG Late Effects Working Group. Overview. Late Effects of Normal Tissues (LENT) scoring system. , 1995, International journal of radiation oncology, biology, physics.

[36]  C. Le,et al.  Goodness of Fit Tests for Proportional Hazards Regression Models , 1992 .

[37]  J. Van Dyk,et al.  Radiation myelopathy following single courses of radiotherapy and retreatment. , 1994, International journal of radiation oncology, biology, physics.

[38]  R. T. Ten Haken,et al.  Prospective study of inner ear radiation dose and hearing loss in head-and-neck cancer patients. , 2005, International journal of radiation oncology, biology, physics.

[39]  H Meertens,et al.  Calculation of the uncertainty in complication probability for various dose-response models, applied to the parotid gland. , 2001, International journal of radiation oncology, biology, physics.

[40]  H. Bartelink,et al.  About tolerance and quality. An important notice to all radiation oncologists. , 1995, Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology.

[41]  Andrew Jackson,et al.  Correlation of dosimetric factors and radiation pneumonitis for non-small-cell lung cancer patients in a recently completed dose escalation study. , 2004, International journal of radiation oncology, biology, physics.

[42]  M. Hoogeman,et al.  Impact of volume and location of irradiated rectum wall on rectal blood loss after radiotherapy of prostate cancer. , 2004, International journal of radiation oncology, biology, physics.

[43]  C. Leemans,et al.  Does radiation dose to the salivary glands and oral cavity predict patient-rated xerostomia and sticky saliva in head and neck cancer patients treated with curative radiotherapy? , 2005, Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology.

[44]  M T Munley,et al.  Radiation-induced pulmonary toxicity: a dose-volume histogram analysis in 201 patients with lung cancer. , 2001, International journal of radiation oncology, biology, physics.