Critical appraisal:Green DM, Whitton JA, Stovall M, Mertens AC, Donaldson SS, Ruymann FB, et al 2003 2

Critical Appraisal

Article being appraised

Green DM, Whitton JA, Stovall M, Mertens AC, Donaldson SS, Ruymann FB, et al. Pregnancy outcome of partners of male survivors of childhood cancer: a report from the Childhood Cancer Survivor Study. J Clin Oncol 2003 Feb 15;21(4):716-21 Available from: http://www.ncbi.nlm.nih.gov/pubmed/12586811.

Applicable clinical question

Are cancer survivors at increased risk of complications during pregnancy, birth and breastfeeding?Are children of cancer survivors at increased risk of physical and developmental abnormalities?

Key Facts

Study Design

cohort study

Study aims:

To evaluate the effect of prior treatment for childhood cancer with radiotherapy, chemotherapy, or both on pregnancy outcome among the partners of men treated for cancer during childhood and adolescence.

Number of Patients:

1227

Of the 7033 male survivors, 4,122 (59%) who answered the question indicated that they had been sexually active. A medical record abstract form was completed for 3,472 (84.2%) of the sexually active male survivors; 1,227 sexually active males reported they sired 2,323 pregnancies.

Reported outcome(s):

Occurrence of pregnancy, the age in years of the survivor at the beginning of the pregnancy (15, 15 to 20, 21 to 25, 26 to 30, 31 to 35, or 35 years), the duration of the pregnancy (12, 12 to 24, 25 to 32, 33 to 37, 38 to 40, or 40 weeks) and the outcome of pregnancy (medical abortion, miscarriage, stillbirth, live birth).

Results of outcome(s):

The sex ratio was 1.0:1.03 for the offspring of the partners of the male patients, compared with 1.24:1.0 among the offspring of the partners of the male siblings (P = .016).
The proportion of pregnancies that resulted in a live birth was significantly lower for the partners of the male survivors than for the partners of the survivors’ siblings (RR, 0.79; 95% confidence interval [CI], 0.65 to 0.96, P = .016).
The RR for a live birth was decreased if the male survivor was treated with surgery and chemotherapy with or without radiotherapy, when compared with the pregnancies of the partners of the male siblings.
The partners of male survivors whose testes were in the radiotherapy field, near the radiotherapy field, or were shielded had very few live births. The rate of stillbirth or miscarriage was not increased among the partners of male survivors whose testes were not irradiated or who received no radiotherapy.
The rate of live births was significantly lower among the partners of male survivors treated with dactinomycin (RR = 0.68; 95% CI, 0.49 to 0.94; P = .02).
The rate of miscarriage was higher for the partners of male survivors treated with more than 5,000 mg/m2 of procarbazine than for those treated with 0 to 5,000 mg/m2 of procarbazine (RR = 2.44, 95% CI , 1.28 to 4.67, P = .007).
The offspring of male survivors who were treated with nonalkylating agent chemotherapy (RR = 3.03; 95% CI, 1.15 to 7.98; P = .025) (Fig 3) were more likely to weigh less than 2,500 g.

Comments on results:

Older study ? applicability of some of the chemotherapeutic agents used.

Includes an economic evaluation

no