Triple negative breast cancer: a retrospective study of Hispanics residing in Puerto Rico.

Objective: Triple-negative breast cancer (TNBC) demonstrates unique clinicopathological characteristics and survival outcomes. Several studies have documented important disparities in Hispanic women compared to other racial/ethnic groups; nevertheless, data on this entity in a population based Latin country are very limited. Our goal was to assess demographic and clinicopathological characteristics in essentially a pure population of Puerto Rican females with TNBC residing in Puerto Rico, as well as to determine their overall survival and progression-free survival in order to compare with published data.

Long-term follow-up of RTOG 88-05: twice-daily external irradiation with brachytherapy for carcinoma of the cervix.

Purpose: To evaluate the efficacy and toxicity of twice-daily external irradiation to the pelvis with brachytherapy for carcinoma of the cervix in a long-term follow-up study.

Methods And Materials: This study was designed to administer twice-daily irradiation doses of 1.2 Gy to the pelvis, 5 d/wk.

Validation of the RTOG recursive partitioning classification for head and neck tumors.

Background: We previously demonstrated that a mathematical technique called recursive partitioning analysis (RPA), when applied to the Radiation Therapy Oncology Group Head and Neck Cancer database, created rules that formed subgroups ("classes") having unique outcomes. We sought to learn if the application of RPA-derived rules to a new head and neck database would create classes that were similarly associated with outcome and thereby validate this technique.

Methods: The rules derived from recursive partitioning analysis of the previous database were used to subgroup an independent, new head and neck cancer database (RTOG 85-27), created as part of a phase III trial of the hypoxic-cell radiosensitizer, Etanidazole.

Irradiation with or without misonidazole for patients with stages IIIB and IVA carcinoma of the cervix: final results of RTOG 80-05. Radiation Therapy Oncology Group.

Purpose: The purpose of this study was to evaluate tumor response, progression-free survival, local tumor control, patterns of relapse, and toxicity in patients with Stages IIIb and IVa squamous cell carcinoma of the uterine cervix treated with irradiation or irradiation and misonidazole. This is a report of the final results of the study.

Methods: This study was a prospective randomized Phase III trial performed by the Radiation Therapy Oncology Group (RTOG).

Recursive partitioning analysis of 1592 patients on four Radiation Therapy Oncology Group studies in inoperable non-small cell lung cancer.

Survival outcome of 1592 analyzable patients on four Radiation Therapy Oncology Group (RTOG) studies in inoperable non-small cell lung cancer were studied utilizing a recursive partitioning analysis (RPA). This approach creates a regression tree according to prognostic variables which partitions into homogenous subsets according to survival. Four protocols, RTOG 83-11, 83-21, 84-03 and 84-07 were analyzed.

Results of a phase II trial of external beam radiation with etanidazole (SR 2508) for the treatment of locally advanced prostate cancer (RTOG Protocol 90-20).

Purpose: RTOG Protocol 90-20 was designed to evaluate the effect of the hypoxic cell sensitizer Etanidazole (SR-2508) on locally advanced adenocarcinoma of the prostate treated with concurrent external beam irradiation.

Methods And Materials: Patients with biopsy-proven adenocarcinoma of the prostate with locally advanced T2b, T3, and T4 tumors were eligible for this study. No patients with disease beyond the pelvis were eligible.

Evolution of the Radiation Therapy Oncology Group clinical trials for head and neck cancer.

During the past 25 years, the Radiation Therapy Oncology Group (RTOG) has played a major role in head and neck cancer clinical research. The major research themes for recent and currently active trials have been: (a) combined modality therapy, (b) altered fractionation radiotherapy, (c) hypoxic cell sensitizers, (d) organ preservation, (e) chemoprevention, and (f) clinical/laboratory correlations. For advanced operable disease, the RTOG showed improved local-regional control with postoperative radiotherapy as compared to preoperative radiotherapy for carcinoma of the supraglottic larynx and hypopharynx.

Recursive partitioning analysis of 2105 patients treated in Radiation Therapy Oncology Group studies of head and neck cancer.

Background: The Radiation Therapy Oncology Group conducts large-scale prospective, randomized trials to test new concepts in cancer patient care and provide information about pretreatment and treatment factors that may influence outcome.

Methods: Recursive partitioning analysis (RPA) was used to examine the data derived from 2105 patients. RPA grouped patients according to the influence of tumor, of host, and of treatment variables on outcome.

Altered fractionation and extended-field irradiation of carcinoma of the cervix.

Conventional radiotherapy for treatment of carcinoma of the cervix consists of five daily fractions of 1.80-2.00 Gy, 5 days/week, up to 40.

Prophylactic extended-field irradiation of para-aortic lymph nodes in stages IIB and bulky IB and IIA cervical carcinomas. Ten-year treatment results of RTOG 79-20.

Objectives: To investigate whether irradiation to the standard pelvic field only improves the response rate and survival in comparison with pelvic plus para-aortic irradiation in patients with high-risk cervical carcinoma, and to investigate patterns of failure and treatment-related toxicity.

Design: Randomized controlled trial from November 1979 to October 1986, with stratification by histology, para-aortic nodal status, and International Federation of Gynecology and Obstetrics (FIGO) stage.

Setting: Radiation Therapy Oncology Group (RTOG) multicenter clinical trial.

Carcinoma of the cervix: patterns of care studies: review of 1978, 1983, and 1988-1989 surveys.

Purpose: A review of the Patterns of Care Studies Process Survey data on carcinoma of the cervix conducted on patients in 1978, 1983, and 1988-89 was carried out to identify changes or trends in the demographics, evaluation, and treatment that might have occurred over this time period.

Methods And Materials: Patterns of Care Studies conducted surveys on patients treated by radiation therapy for cervical carcinoma in 1978, 1983, and 1988-89. These surveys have compiled demographic and treatment data on a total of 993 patients.

Late effects of hyperfractionated radiotherapy for advanced head and neck cancer: long-term follow-up results of RTOG 83-13.

Purpose: The objective of this study was to examine the incidence of late effects of hyperfractionated radiotherapy for head and neck cancer as a function of the dose delivered, as well as the daily interfraction interval. In addition, we wished to examine the influence of other prognostic factors including age, gender, primary site, T- and N-stage, and overall stage on the late effects of hyperfractionated radiotherapy.

Methods And Materials: Between 1983 and 1987, 479 patients with advanced head and neck cancer were entered on a Phase ILE/II dose escalation trial of hyperfractionated radiotherapy.

Results of an RTOG phase III trial (RTOG 85-27) comparing radiotherapy plus etanidazole with radiotherapy alone for locally advanced head and neck carcinomas.

Purpose: The objectives of this study were to determine the efficacy and toxicity of Etanidazole (ETA), a hypoxic cell sensitizer, when combined with conventional radiotherapy (RT) in the management of advanced head and neck carcinomas.

Methods And Materials: From March 1988 to September 1991, 521 patients who had Stage III or IV head and neck carcinomas were randomized to receive conventional RT alone (66 Gy in 33 fractions to 74 Gy in 37 fractions, 5 fractions per week) or RT+ETA (2.0 g/m2 thrice weekly for 17 doses), of whom 504 were eligible and analyzable.

Phase II trial of hormonal cytoreduction with megestrol and diethylstilbestrol in conjunction with radiotherapy for carcinoma of the prostate: outcome results of RTOG 83-07.

Purpose: RTOG 83-07 is a Phase II randomized protocol designed to compare the efficacy and toxicity of Megestrol vs. Diethylstilbestrol (DES) used as cytoreductive agents prior to and during radiotherapy. The end points of this study include tumor clearance rate, effect on serum testosterone, loco-regional control, disease-free interval, and survival.

The role of radiation therapy in the multidisciplinary management of recurrent and metastatic breast cancer.

Carcinoma of the breast is a disease that is associated with 10-year recurrence rates of 25% in operable patients with no spread to the axillary nodes and 75% in patients in whom the tumor has extended to the axillary nodes. Locoregional recurrence rates of close to 50% have been reported in patients with Stage III disease. Adjuvant prophylactic postoperative irradiation can reduce locoregional recurrences to less than 10%.

Twice-daily fractionation of external irradiation with brachytherapy in bulky carcinoma of the cervix. Phase I/II study of the Radiation Therapy Oncology Group 88-05.

Background: Hyperfractionated radiation therapy (HFX), which may permit higher total doses of radiation therapy without increased toxic effects to normal tissues, has been used with pelvic tumors, but its combination with brachytherapy has not been well studied.

Methods: A prospective Phase I/II trial was designed to study HFX with brachytherapy in patients with bulky Stage IB and IIA, IIB, III, and IVA carcinomas of the cervix. HFX doses of 1.

"Compensated" split-course versus continuous radiation therapy of carcinoma of the tonsillar fossa. Final results of a prospective randomized clinical trial of the Radiation Therapy Oncology Group.

The Radiation Therapy Oncology Group conducted a prospective comparison of a compensated split course radiotherapy technique (300 cGy x 10, 3 weeks rest, 300 cGy x 10), versus continuous radiotherapy (200-220 cGy up to 6000-6600 cGy), in 137 evaluable patients. The complete response (CR) was 57% in 63 patients, treated with the split-technique vs 61% in 74 patients submitted to continuous course radiotherapy. The completion of therapy as planned was better in the split-technique, but acute and late tissue reactions were the same.

Radiation therapy of cervical cancer. New developments.

Background: Invasive carcinoma of the cervix will be diagnosed in 13,500 women in the USA in 1992, of which a significant number will require radiation therapy.

Methods: Based on available information one can define optimal workup and staging, optimal radiation therapy, and the possibilities of interaction of radiation with surgery and chemotherapy in these cases.

Results: The pelvic tumor control rates achieved with radiation therapy can reach close to 100% in subclinical tumor (Stage IA), range from 91-98% in Stage IB, but can be as low as 25-34% in Stage IVA.

Interruptions adversely affect local control and survival with hyperfractionated radiation therapy of carcinomas of the upper respiratory and digestive tracts. New evidence for accelerated proliferation from Radiation Therapy Oncology Group Protocol 8313.

Hyperfractionated radiation therapy (HFX) attempts to overcome tumor proliferation during treatment by permitting higher total doses in the same overall time as standard fractionation. Whereas interruptions, including splits, reduce local control with standard fractionation in carcinoma of the upper respiratory and digestive tracts, HFX might compensate for interruptions. Patients were randomized to receive total doses of 6720, 7200, 7680, and 8160 cGy, using 120 cGy twice daily, 5 days per week.

Postsurgical adjuvant chemotherapy with or without radiotherapy in women with breast cancer and positive axillary nodes: a South-Eastern Cancer Study Group (SEG) Trial.

In a prospective study of 622 women with breast cancer, those with one to three histologically positive axillary lymph nodes were randomised after mastectomy to receive cyclophosphamide 100 mg/m2 orally on days 1-14, methotrexate 40 mg/m2 intravenously on days 1 and 8, and fluorouracil 600 mg/m2 intravenously on days 1 and 8 every 28 days for six cycles (CMF x six), or for twelve cycles of the same chemotherapy (CMF x 12). Those with > or = four positive nodes were randomised to one of these two groups or to 5000 cGy of postmastectomy regional radiotherapy (RT) followed by six cycles of the same chemotherapy (RT + CMF x six). With about 10 years median follow-up, there was no significant difference in survival or disease-free survival among the three groups.

Logistics in designing clinical trials for etanidazole (SR 2508): an RTOG experience.

In a Phase II study of etanidazole (SR 2508), the dose of 17 x 2 g/m2 (total drug dose: 34 g/m2) was tested in 33 patients and the toxicity was deemed acceptable. A Phase III trial is now in progress comparing conventional radiotherapy with conventional radiotherapy plus etandizole (2 g/m2 i.v.