Adolescents and young adults with cancer: the scope of the problem and criticality of clinical trials.

In the U.S., older adolescents and young adults with cancer have benefited less from therapeutic advances than did either younger or older patients. One factor that may explain this deficit is the relative lack of participation of patients in this age group on clinical trials of therapies that could improve their outcome. Comparisons were made of the participation of cancer patients on clinical trials in the U.S., as a function of patient age, with the change in national cancer mortality rate; and Surveillance, Epidemiology, End Results (SEER) cancer survival rate as a function of age. The participation rate in cancer treatment trials has been strikingly lower in 15-34-year-olds than in younger or older patients. The nadir has been apparent for both males and females in all of the major ethnic and racial groups. The national cancer mortality reduction and SEER survival improvement shows a similar age dependence. In the U.S., the age-dependence of cancer treatment trial participation, and of improvement in survival prolongation and cancer death rates, are correlated. Regardless of whether there is a causal relationship, the impact on the older adolescent and young adult U.S. population is substantial, adversely affecting the national cost of healthcare, the person-years of life lost, the loss of young people entering the job market, and the scientific knowledge and social implications of cancer during adolescence and early adulthood. National initiatives are underway to address these issues, with special emphasis on increasing the availability and access to clinical trials designed for older adolescents and young adults.

Bleyer A ，Budd T ，Montello M 《-》

The challenges of clinical trials for adolescents and young adults with cancer.

In the United States, Europe, and Australia, and probably all countries of the world, older adolescents and young adults with cancer are under-represented in clinical trials of therapies that could improve their outcome. Simultaneously, the survival and mortality rates in these patients have mirrored the clinical trial accrual pattern, with little improvement compared with younger and older patients. This suggests that the relative lack of participation of adolescent and young adult patients in clinical trials has lessened their chances for as good an outcome as that enjoyed by patients in other age groups. Thus, increased availability of and participation in clinical trials is of paramount important if the current deficits in outcome in young adults and older adolescents are to be eliminated. Regardless of whether there is a causal relationship, the impact of low clinical trial activity on furthering our scientific knowledge and management of cancer during adolescence and early adulthood is detrimental.

Ferrari A ，Montello M ，Budd T ，Bleyer A ... -  《-》

National survival trends of young adults with sarcoma: lack of progress is associated with lack of clinical trial participation.

Young adults with cancer in the U.S. have had less improvement in survival than either younger patients or older patients. The authors attempted to determine whether similar deficits have occurred in young adults with sarcomas and, if so, then why. In 38,144 young adults with sarcoma who were diagnosed during 1975-1998 and were followed by the National Cancer Institute's (NCI) Surveillance, Epidemiology, and End Results Program, the average annual percent change in 5-year survival was derived as a function of patient age. National sarcoma treatment trial data were obtained on 3242 patients who were entered onto NCI-sponsored trials during 1997-2002. 1) For patients with bone and soft-tissue sarcomas, except Kaposi sarcoma (KS), the least survival improvement occurred between age 15 years and age 45 years. For patients with KS, the pattern was reversed, with the greatest survival increase occurring among patients ages 30-44 years. 2) The lowest participation rate in NCI-sponsored sarcoma treatment trials occurred in patients ages 20-44 years. For patients with KS, the highest accrual rate occurred in patients ages 35-44 years. 3) The age-dependent survival improvement and clinical-trial accrual patterns were correlated directly (soft-tissue sarcomas, P < 0.005; bone sarcomas, P < 0.05; KS, P = 0.06), regardless of whether the accrual profile demonstrated a decline or a peak (KS) during early adulthood. The lack of survival prolongation in patients age 15-44 years in the U.S. with non-KS sarcomas may have been a result of their relative lack of participation in clinical trials. If this is true, then reversing the shortfall in survival among young adults with sarcomas, as was accomplished among patients with KS, should benefit from increased clinical trial availability, access, and participation.

Bleyer A ，Montello M ，Budd T ，Saxman S ... -  《CANCER》

National cancer clinical trials: children have equal access; adolescents do not.

Bleyer WA ，Tejeda H ，Murphy SB ，Robison LL ，Ross JA ，Pollock BH ，Severson RK ，Brawley OW ，Smith MA ，Ungerleider RS ... -  《JOURNAL OF ADOLESCENT HEALTH》

Participation of adolescents with cancer in clinical trials.

Ferrari A ，Bleyer A 《CANCER TREATMENT REVIEWS》