Radiotherapy versus concurrent 5-day cisplatin and radiotherapy in locally advanced cervical carcinoma. Long-term results of a phase III randomized trial.

Purpose: To prove the superiority of concurrent radiochemotherapy (RTCT) over radiotherapy (RT) alone in locally advanced cervical carcinoma.

Patients And Methods: In this randomized monocentric phase III study, 566 patients with squamous cell carcinoma of the cervix were included: 284 in arm A (RT) and 282 in arm B (concurrent RTCT with cisplatin 20 mg/m(2) x 5 days). 238 patients (42%) were in stage IIB, 209 (37%) in stage IIIA, and 119 (21%) in stage IIIB.

Capecitabine as salvage treatment in relapsed nasopharyngeal carcinoma: a phase II study.

Purpose: To evaluate the efficacy of capecitabine (Xeloda) as rescue treatment (2nd, 3rd and 4th line) in patients with relapsed nasopharyngeal carcinoma (NPC) in a phase II study.

Patients And Methods: Between 5/2002-11/2005, 23 relapsed NPC patients (17 locoregional relapse, 3 metastatic, 3 locoregional + metastatic) received capecitabine 2500 mg/m(2)/d, days 1-14 every 3 weeks, until progression or for a maximum of 6 cycles.

Patient Characteristics: 23 patients (14 men, 9 women) with median age 46 years (range 15-59); ECOG performance status 1 n=21, 2 n=2; histology: undifferentiated carcinoma (WHO type III) n=21, non-keratinizing epidermoid carcinoma (WHO type II), n=2.

Quality of life and treatment related toxicity in 335 patients with locally advanced cervical carcinoma treated by two chemoradiation regimens.

Purpose: Concomitant chemoradiotherapy (CT/RT) is the gold standard for advanced cervical carcinoma, but with frequent debates over treatment schedules and toxicity. This study compared 2 concomitant CT/RT regimens in terms of quality of life (QoL) and acute toxicity.

Patients And Methods: Between March 2003 and March 2005, 335 patients with stage IIB-IIIB cervical carcinoma were evaluated in a randomized single-center phase III trial at the Oncology Institute Cluj-Napoca.

Clinical results of medium dose rate brachytherapy combined with external beam radiotherapy in the treatment of advanced cervical carcinoma.

Purpose: To evaluate the overall and disease-free survival of patients with advanced cervical carcinoma (FIGO stages IIB-IIIB) treated with external beam radiotherapy (EBRT) and medium dose rate brachytherapy (MDR-BT) plus/minus surgery.

Patients And Methods: One hundred and seven patients received preoperative RT (group A) and 154 were treated with definitive RT (group B); 73 patients in both groups also received cisplatin as radiosensitizer. EBRT delivered as preoperative reached a total dose of 44-46 Gy/pelvis, whereas the definitive RT reached a total dose of 62-64 Gy with standard fractionation.

First-line chemotherapy with topotecan and etoposide in advanced small cell lung cancer. A phase II study.

Purpose: Topotecan has recently shown activity in small cell lung cancer (SCLC) patients. The aim of the present phase II study was to assess the antitumor activity and toxicity of the combination of topotecan plus etoposide in chemotherapynaive patients with advanced SCLC on an outpatient basis.

Patients And Methods: From December 1998 to February 2001 24 previously untreated patients with histologically proven advanced (stage IIIB and IV) SCLC received topotecan 1.

Concurrent chemoradiotherapy with vinorelbine and a platinum compound followed by consolidation chemotherapy for unresectable stage III non-small cell lung cancer: preliminary results of a phase II study.

Purpose: To determine the efficacy, toxicity and survival of concurrent therapy with vinorelbine and a platinum compound with radiotherapy (RT), followed by consolidation chemotherapy with the same drugs, for locally advanced non small cell lung cancer (NSCLC).

Patients And Methods: Fifty-seven patients with stage III NSCLC were included in this phase II study: median age 56 years (range 44-71), males / females 49/8, ECOG performance status (PS) 1/2=27/30, stage IIIA/ IIIB 11/46, squamous cell carcinoma 44, adenocarcinoma 7, adenoid cystic carcinoma 1 and large cell carcinoma 5. Treatment consisted of 2 cycles of chemotherapy with vinorelbine and cisplatin or carboplatin, given concurrently with RT, followed by 2-4 more cycles of consolidation chemotherapy with the same drugs.

Paclitaxel and carboplatin in relapsed or metastatic nasopharyngeal carcinoma: a multicenter phase II study.

Purpose: This multicenter phase II study was conducted to investigate the activity and toxicity of a combination of paclitaxel and carboplatin delivered on an outpatient basis in relapsed/ metastatic nasopharyngeal carcinoma patients.

Patients And Methods: Patients aged>/= 18 years with histologically proven recurrent or metastatic nasopharyngeal carcinoma, an Eastern Cooperative Oncology Group (ECOG) performance status /= 12 weeks were eligible. Measurable disease outside prior radiotherapy ports was required, unless a subsequent progression of the lesion was documented.

Cisplatin and gemcitabine first-line chemotherapy followed by maintenance gemcitabine or best supportive care in advanced non-small cell lung cancer: a phase III trial.

Purpose: The primary objective of this randomized phase III study was to show significant difference in median time to progression (TTP) in patients with advanced NSCLC treated with single-agent gemcitabine maintenance therapy versus best supportive care following gemcitabine plus cisplatin initial first-line therapy.

Patients And Methods: Chemonaive patients with stage IIIB/IV NSCLC received gemcitabine 1,250 mg/m(2) (days 1 and 8) plus cisplatin 80 mg/m(2) (day 1) every 21 days. Patients achieving objective response or disease stabilization following initial gemcitabine plus cisplatin therapy were randomized (2:1 fashion) to receive maintenance gemcitabine (1,250 mg/m(2) on days 1 and 8 every 21 days) plus best supportive care (GEM arm), or best supportive care only (BSC arm).

Gemcitabine, epirubicin, and paclitaxel versus fluorouracil, epirubicin, and cyclophosphamide as first-line chemotherapy in metastatic breast cancer: a Central European Cooperative Oncology Group International, multicenter, prospective, randomized phase III trial.

Background: The objectives of this phase III trial were to compare the time to progressive disease (TtPD), overall response rate (ORR), overall survival, and toxicity of gemcitabine, epirubicin, and paclitaxel (GET) versus fluorouracil (FU), epirubicin, and cyclophosphamide (FEC) as first-line therapy in patients with metastatic breast cancer (MBC).

Patients And Methods: Female patients aged 18 to 75 years with stage IV and measurable MBC were enrolled and randomly assigned to either gemcitabine (1,000 mg/m(2), days 1 and 4), epirubicin (90 mg/m(2), day 1), and paclitaxel (175 mg/m(2), day 1) or FU (500 mg/m(2), day 1), epirubicin (90 mg/m(2), day 1), and cyclophosphamide (500 mg/m(2), day 1). Both regimens were administered every 21 days for a maximum of eight cycles.

Concomitant radiochemotherapy vs radiotherapy alone in patients with head and neck cancer: a Hellenic Cooperative Oncology Group Phase III Study.

The primary objective of the present randomized phase III trial was to compare the 3-yr survival rate of patients treated with standard fractionated radiotherapy (RT) alone or with the same RT concomitantly with cisplatin (DDP) or carboplatin (Cb). From January 1995 until July 1999, 124 patients with histologically proven locally advanced non-nasopharyngeal head and neck cancer (HNC) were randomized to receive either RT monotherapy (70 Gy, Group A) or the same RT concomitantly with DDP (100 mg/m2 on d 2, 22, 42, Group B) or Cb (7 AUC on d 2, 22, 42, Group C). There were no significant differences in complete response rates between patients treated with RT alone or combined chemoradiotherapy.

Prognostic impact of tumor volumetry in patients with locally advanced head-and-neck carcinoma (non-nasopharyngeal) treated by radiotherapy alone or combined radiochemotherapy in a randomized trial.

Purpose: Tumor volume (TV) is one of the main reported factors determining the outcome of treatment in head-and-neck carcinomas. In this study, the prognostic impact of TV was explored in the context of a randomized trial with the patients assigned to receive standard radiotherapy (RT) alone or RT plus platinum compounds (RT alone, RT plus cisplatin, or RT plus carboplatin).

Methods And Materials: The tumor outlines were traced and digitized on each pretreatment CT slice for each of the 101 patients studied.

Doubling epirubicin dose intensity (100 mg/m2 versus 50 mg/m2) in the FEC regimen significantly increases response rates. An international randomised phase III study in metastatic breast cancer. The Epirubicin High Dose (HEPI 010) Study Group.

Purpose: A phase III study was performed in patients with metastatic breast cancer (MBC) to evaluate the effect on response rate and survival of a doubling of the epirubicin dose intensity.

Patients And Methods: Four hundred fifty-six patients were randomised to receive either epirubicin 100 mg/m2 or 50 mg/m2 in combination with 5-FU (500 mg/m2) and cyclophosphamide (500 mg/m2) (FEC 100 vs. FEC 50) i.

Morphometric grading of laryngeal squamous cell carcinomas.

The authors have used the point counting method for the morphometric assessment of the histological aspect of laryngeal carcinoma. The results suggest that subjective histopathological grading tends to overestimate the tumor grade. The implications of these data for the prediction of prognosis and selection of therapy are briefly discussed.