James A. Mailliard

A Phase III Study of radiation therapy plus carmustine with or without recombinant interferon-α in the treatment of patients with newly diagnosed high-grade glioma

The current study was conducted to determine whether the addition of interferon‐α (IFN‐α) to treatment with radiation therapy and carmustine (BCNU) improves time to disease progression or overall survival in patients with high‐grade glioma.

A phase II study of paclitaxel plus carboplatin as first-line chemotherapy for women with metastatic breast carcinoma.

This Phase II multicenter study evaluated the efficacy and toxicity of paclitaxel (200 mg/m2 by 3‐hour infusion) with carboplatin (area under the curve 6 mg/mL per minute) administered every 3 weeks as first‐line therapy for women with metastatic breast carcinoma.

Mortality associated with daily bolus 5-fluorouracil/leucovorin administered in combination with either irinotecan or oxaliplatin: Results from Intergroup Trial N9741

Intergroup Trial N9741 evaluated 5‐fluorouracil (5‐FU)/leucovorin (LV) administered in conjunction with either irinotecan or oxaliplatin in the first‐line treatment of advanced colorectal carcinoma (CRC). The current report describes two treatment arms that were withdrawn from the protocol due to unexpected treatment‐related toxicities and a high mortality rate. The complications observed in these arms highlight the importance of aggressive and immediate supportive care in the management of digestive toxicity.

A randomized trial of tamoxifen alone or combined with octreotide in the treatment of women with metastatic breast carcinoma

Tamoxifen (TAM) is generally considered the hormonal agent of choice for postmenopausal women with hormone receptor positive breast carcinoma. The somatostatin analogues, including octreotide, have demonstrated inhibition of breast carcinoma cell lines and multiple endocrinologic actions, including reduction of insulin‐like growth factor I (IGF‐I), a potent mitogen for breast carcinoma cells. In an attempt to improve the efficacy of TAM, this randomized trial was performed.

Results of combined-modality therapy for limited-stage small cell lung carcinoma in the elderly

A Phase III trial was conducted by the North Central Cancer Treatment Group to determine whether chemotherapy (etoposide and cisplatin) plus either twice‐daily radiotherapy (BIDRT) or once‐daily radiotherapy (QDRT) resulted in a better outcome for patients with limited‐stage small cell lung carcinoma (LD‐SCLC). No difference in survival was identified between the two arms. The current analysis examined the relation between age and outcome for patients treated during this trial.

A Randomized Phase II Trial of Two Dosage Levels of Letrozole as Third-Line Hormonal Therapy for Women with Metastatic Breast Carcinoma

It is common practice to utilize a series of different hormonal agents in the treatment of postmenopausal women who, despite disease progression, continue to be candidates for hormonal therapy on a clinical basis. Letrozole is a new highly selective and potent aromatase inhibitor. There are limited data on third‐line hormonal therapy in general, and this study was undertaken to evaluate letrozole in this context.

Phase II trials of 5-fluorouracil and leucovorin in patients with metastatic gastric or pancreatic carcinoma

Previous trials in patients with colorectal carcinoma have indicated that enhancement of 5‐fluorouracil (5‐FU) by leucovorin (LV) can result in an improved response rate and increased survival.

A phase III evaluation of a somatostatin analogue (octreotide) in the treatment of patients with asymptomatic advanced colon carcinoma

Background. The purpose of this study was to determine by randomized, controlled, double‐blind evaluation whether therapy with the somatostatin analogue, octreotide, would delay tumor progression and improve survival of patients with metastatic colorectal carcinomas who were ambulatory with no significant symptoms.

A phase III trial of mitomycin C alone versus mitomycin C, vinblastine, and cisplatin for metastatic squamous cell lung carcinoma

Background. In an effort to confirm the efficacy of mitomycin C against metastatic squamous cell lung carcinoma and to compare the efficacy of single‐agent therapy with a combination containing cisplatin, the authors conducted a randomized Phase 111 trial of mitomycin C alone versus mitomycin C, vinblastine, and cisplatin (MVP).

Alternating chemotherapy with etoposide plus cisplatin and topotecan plus paclitaxel in patients with untreated, extensive-stage small cell lung carcinoma: A phase II trial of the North Central Cancer Treatment Group

The objective of this study was to test the response rate and toxicity of alternating chemotherapy in previously untreated patients with extensive‐stage small cell lung carcinoma (SCLC).