RESUMEN
We report the 8-year follow-up of 34 patients aged >/= 69 years old with NHL included in a phase IIb open-label randomized parallel groups study to evaluate the effectiveness of amifostine in preventing the toxicity of cyclophosphamide, doxorubicin, vincristine and prednisone [CHOP regime]. Patients were randomized to receive classical CHOP [cyclophosphamide 750 mg/ m[2], doxorubicin 50 mg/m[2], vincristine 1.4 mg/m[2] [maximum 2 mg] on day 1 and prednisone 100 mg/day for 5 days] or CHOP plus amifostine [6 cycles of amifostine 910 mg/m[2] on day 1]. Efficacy [time to progression, TTP; disease-free survival, DFS; overall survival, OS] and toxicity endpoints were evaluated. Thirty-four patients were randomized to A-CHOP [n=18] or CHOP [n=16]. Patients with A-CHOP vs CHOP had significantly lower toxicity; neutropenia grade 4 ocurred in 13/92 [13%] vs 23/85 [27%, P=0.007] cycles, febrile neutropenia in 3/92 A-CHOP [3%] vs 8/85 [10%, P=.056] CHOP cycles, hospitalization for toxicity in 4/92 [4%] A-CHOP vs 11/85 [13%, P=.05] CHOP cycles. Median hospitalization stay for toxicity was 5 days with A-CHOP vs 8 days with CHOP [P=.05]. There were no significant differences at 8 years in TTP [A-CHOP, 48.9% vs CHOP, 36.3%; P=.65], DFS [A-CHOP, 72.9% vs CHOP 55.6%; P=.50] and OS [A-CHOP, 44.3% vs CHOP, 54.4%]. There was no long-term toxicity of clinical interest. The only prognostic factor identified to 8 years was the International Prognostic Index [IPI low/low intermediate risk vs high intermediate/high risk; HR=2.98; CI 95%:1.01-8.77; P=.048]. These results show that amifostine can be added to the standard CHOP treatment schedule with less acute toxicity and without influencing the outcome
RESUMEN
This study was conducted to determine the prognostic effect hormone receptor [HR] status in early HER2 positive [HER2+] breast cancer patients, since it has not yet been established whether HR status can be used in the prognosis of patients with [HER2+] breast cancer. We obtained data from 299 patients with early HER2+ breast cancer who underwent surgery and received standard adjuvant chemotherapy, hormonal therapy and/or radiation between 2000 and 2002 at the Instituto Nacional de Enfermedaldes Neoplasticas, Peru. Clinical and pathological features were compared. Endpoints analyzed were disease free survival [DFS] and overall survival [OS]. Overall, 155 patients were HR-positive [HR+] and 144 were negative [HR-]. The two groups had similar characteristics except for histologic grade and extracapsular extension. With a median follow-up of 93 months, 5-year DFS was statistically different between the two groups: 65.0% for [HER2+/HR-] and 74.6% for the [HER2+/HR+] patients [P=.045]. OS at 5 years was not statistically different between the two groups with 75.5% for [HER2+/HR-] patients and 82.4% for the [HER2+/HR+] [P=.140]. Patients with [HER2+/HR-] breast cancers treated with surgery and standard adjuvant chemotherapy exhibited a statistically worse DFS compared to those with [HER2+/HR+] tumors. However, OS was similar in both groups