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Study Title and Description

Orthovoltage radiotherapy for nonmelanoma skin cancer (NMSC): Comparison between 2 different schedules.



Key Questions Addressed
1 Comparison of interventions
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Primary Publication Information
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TitleData
Title Orthovoltage radiotherapy for nonmelanoma skin cancer (NMSC): Comparison between 2 different schedules.
Author Pampena R., Palmieri T., Kyrgidis A., Ramundo D., Iotti C., Lallas A., Moscarella E., Borsari S., Argenziano G., Longo C.
Country Dermatology Unit "Daniele Innocenzi" Department of Medical and Surgical Sciences and Biotechnologies, Sapienza University of Rome, Polo Pontino, Terracina, Italy.
Year 2016
Numbers Pubmed ID: 26589877

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Comparative studies
Arms
Number Title Description Comments
1 3675 cGy
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2 4500 cGy
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Design Details
Question... Follow Up Answer Follow-up Answer
Publication or abstract? Publication
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Study design Retrospective nRCS
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Multicenter etc. Single center
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Country/Region Italy
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Funding No industry support
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Inclusion criteria Histologically verified NMSC
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Exclusion criteria lymphatic or visceral metastases
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N Enrolled/Randomized/Analyzed
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Notes/Comments
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Method of diagnosis ... Describe Biopsy/pathologic confirmation ... histologically confirmed
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Preoperative assessment of clinical size of the tumor ... not reported ...
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Percent non-primary (recurrent)
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Secondary size assessment
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Baseline Characteristics
Question 3675 cGy 4500 cGy Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 81.3 73.3
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8.7 10.2
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Gender/Racial descent 108 53
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45.8 35.6
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Lesion location 21 8
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8.9 5.4
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limbs limbs
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5 8
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2.1 5.4
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trunk trunk
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210 89.0 head/neck 133 89.2 head/neck
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Skin type (Fitzpatrick score) No data entered.
Number of lesions per patient 215 136
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78.2 84.5
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26 24
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9.4 14.9
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34 1
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12.4 0.6
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Previous treatments No data entered.
Immunocompromized status No data entered.
Number of patients/lesions 236 149 385
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275 161 436
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236 149 385
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275 161 436
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0 0 0
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0 0 0
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236 149 385
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275 161 436
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Lesion extent number of people 181 128
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Lesion extent number of people 93 31
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Results & Comparisons


Results Data
Hazard Ratio (HR) 95% CI low 95% CI high P-Value Adjusted For:
Outcome: Recurrence or relapse      Population: All Participants Between-Arm Comparisons
Time Point Measure 3675 cGy 4500 cGy Comparison Measure 3675 cGy vs. 4500 cGy


100 months

N Analyzed 275 161 0.483
Counts 15 6 0.065
Percentage 5.5 3.7 3.582
0.477
Multivariate Cox models were constructed to determine which factors CAPSULE SUMMARY d Radiotherapy is a valuable option for some patients with nonmelanoma skin cancer. d There was no significant difference in overall survival, disease-free survival, or cosmetic outcome comparing a daily radiotherapy regimen versus a hypofractionated one. d A weekly hypofractionated regimen of orthovoltage radiotherapy appears as the best option in elderly disabled patients. J AM ACAD DERMATOL FEBRUARY 2016 342 Pampena et al 17€bow - is it nahospedie ? to the assessor blinbdeedcause of clinic stwotre ? could independently affect survival. Various models were compared by the likelihood ratio test.
95% CI low 95% CI high P-Value Adjusted For: Risk Ratio (RR)
Outcome: Cosmetic outcome (categorical)      Population: All Participants Between-Arm Comparisons
Time Point Measure 3675 cGy 4500 cGy Comparison Measure 3675 cGy vs. 4500 cGy


100 months

N Analyzed 275 161 0.170
Counts 212 143 6.473
Percentage 77.1 88.8 0.960
Multivariate logistic regression for favorable cosmetic outcome. Reported RR mutually adjusted for all variables in the model.
1.048
Hazard Ratio (HR) 95% CI low 95% CI high P-Value Adjusted For:
Outcome: Long-term Mortality      Population: All Participants Between-Arm Comparisons
Time Point Measure 3675 cGy 4500 cGy Comparison Measure 3675 cGy vs. 4500 cGy


100 months

N Analyzed 236 149 0.662
Counts 72 24 0.387
Percentage 30.5 16.1 1.131
0.131
Multivariate Cox models were constructed to determine which factors CAPSULE SUMMARY d Radiotherapy is a valuable option for some patients with nonmelanoma skin cancer. d There was no significant difference in overall survival, disease-free survival, or cosmetic outcome comparing a daily radiotherapy regimen versus a hypofractionated one. d A weekly hypofractionated regimen of orthovoltage radiotherapy appears as the best option in elderly disabled patients. J AM ACAD DERMATOL FEBRUARY 2016 342 Pampena et al 17€bow - is it nahospedie ? to the assessor blinbdeedcause of clinic stwotre ? could independently affect survival. Various models were compared by the likelihood ratio test.
Outcome: Lack of histological clearance      Population: All Participants
Time Point Measure 3675 cGy 4500 cGy


100 months

N Analyzed 236 149
Counts 14 0
Percentage 5.9 0
Outcome: Adverse events: Any      Population: All Participants
Time Point Measure 3675 cGy 4500 cGy


100 months

N Analyzed 236 149
Counts 14 6
Percentage 5.9 4.0
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure 3675 cGy 4500 cGy


100 months

N Analyzed 275 161
Counts 22 10
Percentage 8.0 6.2
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure 3675 cGy 4500 cGy


100 months

N Analyzed 275 161
Counts 6 0
Percentage 2.2 0
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure 3675 cGy 4500 cGy


100 months

N Analyzed 275 161
Counts 4 2
Percentage 1.4 1.3


Quality Dimensions
Dimension Value Notes Comments
RCT:....Adequate generation of a randomized sequence reported
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RCT:....Adequate allocation concealment reported
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RCT:....Adequate blinding of PATIENTS reported
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RCT:....Adequate blinding of PROVIDERS reported
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ALL....Adequate blinding of OUTCOME ASSESSORS reported Yes OS and DFS likely not affected by blinding. Cosmetic outcome assessor blinded
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ALL.....Incomplete results data: are more than 20% missing for any eligible outcome in any group? No no missing
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ALL.....Selective Reporting (judgement - put directly into notes field). No all 3 outcomes reported
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RCT.....Is the treatment effect by Intention to treat?
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ALL....Group similarity at baseline. Yes nothing > 20% differential, mean age may be of concern
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ALL....Additional Bias: Bias due to problems not covered elsewhere. (judgement - put directly into notes field)
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ALL (with AE results)....Were reported adverse events (of interest) precisely defined No Data no AEs
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Overall, by outcome (judgement - put directly into notes field) Moderate - NRCS, no AEs
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ALL.....Incomplete results data: Is there differential missingness (more than 20%) between arms for any eligible outcome? No no missing
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Quality Rating
No quality rating data was found.