Long-term outcomes of concomitant cisplatin plus radiotherapy versus radiotherapy alone in patients with stage IIIB squamous cervical cancer: A randomized controlled trial.

OBJECTIVE: The present analysis determined the disease free survival (DFS) and overall survival (OS) at up to 14 years of follow-up in women who participated in our previous phase 3 randomized controlled clinical trial, in which women with stage IIIB squamous cervical cancer received either cisplatin plus RT or RT alone for treatment. The first study showed that the addition of cisplatin to RT offered a significant benefit in DFS, but not in OS. METHODS: The present analysis examined DFS and OS in 146 women from the original cohort (72 patients in the CRT arm and 74 patients in the RT-only arm) with follow-up of up to 14 years. RESULTS: Longer term follow-up showed that treatment with CRT offers a significant benefit in DFS and OS compared with treatment with RT only. Patients who received RT alone had significantly worse OS (HR, 1.88; 95% CI, 1.09-3.24) and DFS (HR, 1.82; 95% CI, 1.07-3.08) compared with patients who received CRT. The multivariate analyses also showed that the patients with baseline Karnofsky performance status (KPS) <90% showed significantly worse OS (HR, 3.11; 95% CI, 1.78-5.43), as did those with hemoglobin <10 mg/dL (HR, 4.32; 95% CI, 2.23-8.36). Patients with baseline KPS < 90% showed significantly worse DFS (HR, 2.83; 95% CI, 1.60-5.01), as did those with hemoglobin <10 mg/dL (HR, 4.16; 95% CI, 2.17-7.95). CONCLUSIONS: For stage IIIB cervical cancer, treatment with CRT offers a significant benefit in DFS and OS compared with treatment with RT only.

Concomitant cisplatin plus radiotherapy and high-dose-rate brachytherapy versus radiotherapy alone for stage IIIB epidermoid cervical cancer: a randomized controlled trial.

PURPOSE: The benefits of chemoradiotherapy (CRT) for cervical cancer compared with radiation (RT) alone seem to diminish in later-stage disease. However, these modalities have not been directly compared for disease-free interval (DFI) and overall survival (OS) of women with stage IIIB cervical cancer. PATIENTS AND METHODS: We conducted a randomized controlled clinical trial comparing DFI and OS of 147 women with stage IIIB squamous cervical cancer who received either cisplatin plus RT (CRT) or RT alone (72 patients in the CRT group and 75 patients in the RT-only group). RESULTS: The CRT group had significantly better DFI (hazard ratio [HR], 0.52; 95% CI, 0.29 to 0.93; P = .02). However, patients in the CRT group did not have significantly better OS than those in the RT-only group (HR, 0.67; 95% CI, 0.38 to 1.17; P = .16). Toxicity was graded according to criteria of the Radiation Therapy Oncology Group. The organs affected (excluding hematologic effects) did not differ significantly between groups. Also, late toxicity events and organs affected were not significantly disproportionate between the study groups. CONCLUSION: For stage IIIB cervical cancer, the addition of cisplatin offers a small but significant benefit in DFI, with acceptable toxicity.

Adjuvant radiotherapy in early stage endometrial cancer.

OBJECTIVE: To compare the rates of overall survival (OS), disease-free survival (DFS) and toxicity in different techniques of postoperative radiotherapy for stage IA endometrioid adenocarcionoma of endometrium, histological grades 1and 2. METHODS: A historical comparison between treatment regimens was performed, and 133 women with a minimum follow-up of 5 years were included. Teletherapy (TELE group), with 22 patients treated from 1988 to 1996, with a 10 MV linear accelerator, average dose 46.2 Gy. Low dose rate brachytherapy (LDRB group) was performed between 1992 and 1995, in 19 women, with an insertion of Cesium 137, at a 60 Gy dose. Fourteen women operated between 1990 and 1996 did not receive radiotherapy (NO RT group). High dose rate brachytherapy was performed in 78 patients (HDRB group), from 1996 to 2004, in five weekly 7 Gy insertions, prescribed at 0.5 cm from the vaginal cylinder. RESULTS: The 5-year disease-free survival was 94.6% for the HDRB group, 94.1% for the LDRB group, 100% for the TELE group and NO RT groups (p = 0.681). The 5-year overall survival was 86.6% for the HDRB group, 89.5% for the LDRB group and 90% for the TELE group and NO RT groups (p = 0.962). Grades 3-5 late toxicity was 5.3% in LDRB group and 27.3% for the TELE group (p < 0.001). CONCLUSION: Patients submitted to adjuvant teletherapy showed very high toxicity, which contraindicates that treatment for those patients. There may be a role for adjuvant HDRB, but randomized controlled trials are still needed to evaluate its benefit.

Adjuvant radiotherapy in early stage endometrial cancer / Radioterapia adjuvante para câncer do endométrio estádio inicial

OBJECTIVE: To compare the rates of overall survival (OS), disease-free survival (DFS) and toxicity in different techniques of postoperative radiotherapy for stage IA endometrioid adenocarcionoma of endometrium, histological grades 1and 2. METHODS: A historical comparison between treatment regimens was performed, and 133 women with a minimum follow-up of 5 years were included. Teletherapy (TELE group), with 22 patients treated from 1988 to 1996, with a 10 MV linear accelerator, average dose 46.2 Gy. Low dose rate brachytherapy (LDRB group) was performed between 1992 and 1995, in 19 women, with an insertion of Cesium 137, at a 60 Gy dose. Fourteen women operated between 1990 and 1996 did not receive radiotherapy (NO RT group). High dose rate brachytherapy was performed in 78 patients (HDRB group), from 1996 to 2004, in five weekly 7 Gy insertions, prescribed at 0.5 cm from the vaginal cylinder. RESULTS: The 5-year disease-free survival was 94.6 percent for the HDRB group, 94.1 percent for the LDRB group, 100 percent for the TELE group and NO RT groups (p = 0.681). The 5-year overall survival was 86.6 percent for the HDRB group, 89.5 percent for the LDRB group and 90 percent for the TELE group and NO RT groups (p = 0.962). Grades 3-5 late toxicity was 5.3 percent in LDRB group and 27.3 percent for the TELE group (p < 0.001). CONCLUSION: Patients submitted to adjuvant teletherapy showed very high toxicity, which contraindicates that treatment for those patients. There may be a role for adjuvant HDRB, but randomized controlled trials are still needed to evaluate its benefit.

OBJETIVO: Comparar as taxas de sobrevida global (SG), sobrevida livre de doença (DFS) e de toxicidade em diferentes técnicas de radioterapia pós-operatória para adenocarcionoma endometrioide do endométrio estádio IA, graus histológicos 1 e 2. MéTODOS: Realizou-se uma comparação histórica entre regimes de tratamento, incluindo 133 mulheres com seguimento mínimo de cinco anos. Teleterapia (grupo TELE), com 22 pacientes, de 1988 a 1996, tratadas com acelerador linear 10 MV, dose média de 46,2 Gy. Braquiterapia de baixa taxa de dose (grupo LDRB), realizada entre 1992 e 1995, em 19 mulheres, com uma inserção de Césio 137, dose de 60 Gy. Quatorze mulheres operadas entre 1990 e 1996 não receberam radioterapia (grupo NO RT). Braquiterapia de alta taxa de dose foi realizada em 78 pacientes (grupo BATD), 1996-2004, cinco inserções semanais de 7 Gy, a 0,5 cm do cilindro vaginal. RESULTADOS: A DFS em cinco anos foi de 94,6 por cento para o grupo BATD, 94,1 por cento para o grupo LDRB, 100 por cento para os grupos TELE e RT (p = 0,681). A sobrevida global em cinco anos foi de 86,6 por cento para o grupo BATD, 89,5 por cento para o grupo LDRB e 90 por cento para os grupos TELE e NO RT (p = 0,962). A toxicidade tardia graus 3-5 foi de 5,3 por cento no grupo LDRB e 27,3 por cento para o grupo TELE (p < 0,001). CONCLUSãO: Pacientes submetidos à teleterapia adjuvante apresentaram toxicidade muito elevada, o que contraindica o tratamento para essas pacientes. Pode haver um papel para a BATD adjuvante, mas estudos controlados randomizados são necessários para avaliar seu benefício.

Brachytherapy for stage IIIB squamous cell carcinoma of the uterine cervix: survival and toxicity.

OBJECTIVE: To compare survival and toxicity of three different treatments for stage IIIB cervix cancer: low-dose-rate (LDR), high-dose-rate (HDR) brachytherapy and association of HDR and chemotherapy. METHODS: Between 1985 and 2005, 230 patients with FIGO stage IIIB squamous cell carcinoma of the uterine cervix received 4-field pelvic teletherapy at doses between 40 and 50.4 Gy, with a different complementation in each group. The LDRB group, with 42 patients, received one or two insertions of LDR, with Cesium-137, in a total dose of 80 to 100 Gy at point A. The HDR group, 155 patients received HDR in 4 weekly 7 Gy fractions and 9 Gy to 14.4 Gy applied to the involved parametria. The CHT group, 33 patients, were given the same treatment as the HDR group and received 5 or 6 weekly cycles of cisplatin, 40 mg per m(2). RESULTS: The five-year progression-free survival (PFS) was 60% for the HDR group and 45% for the LDR group, and the two-year PFS for the CHT group was 65% (p = 0.02). The five-year Overall Survival (OS) was 65% for the HDR group and 49% for the LDR group. The two-year OS was 86% for the CHT group (p = 0.02). Rectum toxicity grade II was 7% for the LDR group, 4% for the HDR group and 7% for the CHT group that had one case of rectum toxicity grade IV. CONCLUSION: Patients that received HDR had better OS and PFS. The Chemotherapy-HDR association showed no benefit when compared to HDR only. Toxicity rates showed no difference between the three groups.

Brachytherapy for stage IIIB squamous cell carcinoma of the uterine cervix: survival and toxicity / Braquiterapia para carcinoma epidermóide do colo do útero estádio IIIB: sobrevida e toxicidade

OBJECTIVE: To compare survival and toxicity of three different treatments for stage IIIB cervix cancer: low-dose-rate (LDR), high-dose-rate (HDR) brachytherapy and association of HDR and chemotherapy. METHODS. Between 1985 and 2005, 230 patients with FIGO stage IIIB squamous cell carcinoma of the uterine cervix received 4-field pelvic teletherapy at doses between 40 and 50.4 Gy, with a different complementation in each group. The LDRB group, with 42 patients, received one or two insertions of LDR, with Cesium-137, in a total dose of 80 to 100Gy at point A. The HDR group, 155 patients received HDR in 4 weekly 7 Gy fractions and 9 Gy to 14.4 Gy applied to the involved parametria. The CHT group, 33 patients, were given the same treatment as the HDR group and received 5 or 6 weekly cycles of cisplatin, 40 mg per m2. RESULTS: The five-year progression-free survival (PFS) was 60 percent for the HDR group and 45 percent for the LDR group, and the two-year PFS for the CHT group was 65 percent (p = 0.02). The five-year Overall Survival (OS) was 65 percent for the HDR group and 49 percent for the LDR group. The two-year OS was 86 percent for the CHT group (p = 0.02). Rectum toxicity grade II was 7 percent for the LDR group, 4 percent for the HDR group and 7 percent for the CHT group that had one case of rectum toxicity grade IV. CONCLUSION: Patients that received HDR had better OS and PFS. The Chemotherapy-HDR association showed no benefit when compared to HDR only. Toxicity rates showed no difference between the three groups.

OBJETIVO: Comparar três diferentes tratamentos para câncer de colo do útero, estádio IIIB: braquiterapia de baixa taxa de dose (LDR), alta taxa de dose (HDR) e associação entre HDR e quimioterapia, quanto à sobrevida e toxicidade. MÉTODOS: Entre 1985 e 2005, 230 pacientes com carcinoma epidermoide de colo do útero estádio IIIB receberam teleterapia pélvica em quatro campos, doses entre 40 e 50.4 Gy, e três complementações diferentes. Grupo LDR, com 42 pacientes, recebeu uma ou duas inserções de LDR, com Césio-137, na dose total de 80 a 100Gy no ponto A. Grupo HDR, 155 pacientes, com HDR em quatro frações semanais de 7 Gy, e 9 Gy a 14.4 Gy nos paramétrios acometidos. Grupo CHT, 33 pacientes, tratadas da mesma forma que o grupo HDR, mais cinco ou seis ciclos semanais de cisplatina, 40 mg por m2. RESULTADOS: A sobrevida livre de progressão em cinco anos (PFS) foi 60 por cento no grupo HDR e 45 por cento no grupo LDR, e a PFS em dois anos para o grupo CHT foi 65 por cento (p = 0.02). A sobrevida global em cinco anos (OS) foi 65 por cento para o grupo HDR e 49 por cento para o grupo LDR. A OS em dois anos foi 86 por cento para o grupo CHT (p = 0.02). Toxicidade retal grau II foi 7 por cento no grupo LDR, 4 por cento no grupo HDR e 7 por cento no grupo CHT, que teve um caso de toxicidade retal grau IV. CONCLUSÃO: Pacientes que receberam HDR tiveram melhores índices de sobrevida. A associação quimioterapia-HDR não mostrou benefício quando comparada com apenas HDR. Os índices de toxicidade não foram diferentes.