Background: Human papillomavirus (HPV) is a crucial etiological factor for cervical cancer (CC) development. From a diagnostic view-point, the consistent presence of HPV in CC allows the viral DNA to be used as a genetic marker. The aims of this study were to evaluate the presence, physical status and clinical significant of HPV DNA in circulation of CC patients.
This study reports the MTD, recommended phase 2 dose (RP2D), and preliminary efficacy of alpelisib or buparlisib used in combination with tamoxifen plus goserelin in premenopausal patients with hormone receptor-positive (HR þ), HER2-negative (HER2 À) advanced breast cancer (ABC). Patients and Methods: This study enrolled premenopausal women with HR þ , HER2 À ABC. Patients received tamoxifen (20 mg once daily) and goserelin acetate (3.6 mg every 28 days) with either alpelisib (350 mg once daily; n ¼ 16) or buparlisib (100 mg once daily; n ¼ 13) in 28-day cycles until MTD was observed. Results: The criteria for MTD were not met for both alpelisib and buparlisib. The RP2D of alpelisib and buparlisib in combination with tamoxifen and goserelin were 350 mg and 100 mg, respectively. Both combinations met protocol-specified criteria for tolerability. The most common grade 3/4 treatment-emergent adverse events (TEAE) were hypokalemia (12.5%), hyperglycemia (6.3%), and rash (6.3%) for alpelisib and alanine aminotransferase increase (30.8%), aspartate aminotransferase increase (23.1%), and anxiety (15.4%) for buparlisib. TEAEs led to treatment discontinuation in 18.8% and 53.8% of alpelisib-and buparlisib-treated patients, respectively. Progression-free survival was 25.2 months in the alpelisib group and 20.6 months in the buparlisib group. Conclusions: The RP2Ds of alpelisib and buparlisib were 350 mg and 100 mg, respectively. No unexpected safety findings were reported. Although an early-phase study, data suggest that alpelisib plus endocrine therapy may be a potentially efficacious treatment that warrants further evaluation for premenopausal patients with HR þ , HER2 À ABC.
Aim
To report the long-term local control and survival of patients with early breast cancer who had hypofractionated whole breast irradiation with concomitant boost (Hypo-CB).
Methods and materials
Between October 2009 and June 2010, 73 patients with early breast cancer (T1-3N0-1M0) who underwent breast conserving surgery were enrolled into the study. Thirty-six of these participants received 50 Gy of conventional irradiation in 25 fractions over 5 weeks to the whole breast with a sequential boost to the tumor bed with 10–16 Gy in 5–8 fractions (Conv-SEQ). The other 37 participants received a hypofractionated dose of 43.2 Gy in 16 fractions with an additional daily concomitant boost (CB) of 0.6 Gy over 3 weeks (Hypo-CB).
Results
At a median follow-up time of 123 months, ipsilateral local recurrence (ILR) was found in 3 participants, 1 of whom was in the hypofractionated group. All 3 ILR were true local recurrence (TR). There were no significant differences in the 10-year disease free survival (DFS) and 10-year overall survival rates (OS) between the conventional and hypofractionated groups (93.9% vs. 94.4%, p = 0.96 and 91.9% vs. 91.6%, p = 0.792, respectively).
Conclusion
This study showed that the effectiveness, DFS and OS were comparable between hypofractionated whole breast irradiation with a CB and the conventional irradiation with a sequential boost.
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