Oncology NEWS International Vol 17 No 3

Recentin headed to phase III in first-line colon ca

March 02, 2008

Based on Independent Data Monitoring Committee review of three phase II trials, AstraZeneca’s HORIZON III phase II/III study of its antiangiogenesis agent Recentin will progress directly into phase III. The study is a head-to-head comparison of first-line Recentin (cediranib, AZD2171) plus FOXFOX vs bevacizumab (Avastin) plus FOLFOX in patients with metastatic colorectal cancer

Topo 2 alpha test FDA approved

March 02, 2008

TOP2A FISH pharmDx assay has received FDA approval for use as an adjunct to existing clinical and pathological information in determining the prognosis for patients with relatively high-risk breast cancer.

RFA provides sustained pain relief in osteoid osteoma

March 02, 2008

CT-guided radiofrequency ablation (RFA) offers long-term pain reduction in patients with osteoid osteoma, making RFA a viable alternative to open surgery, according to researchers from Seoul, South Korea.

Renal ca surgery often determined by doctors’ practice style

March 02, 2008

A new study shows that the type of surgery a patient with renal cancer receives depends more on the surgeon’s preference than on the patient’s tumor size, demographic characteristics, or general medical health (Miller et al: Cancer, published online March 10, 2008, DOI: 10.1002/cncr.23372).

Partial nephrectomy underutilized for small renal tumors

March 02, 2008

;Women, older patients, and patients with cerebrovascular disease who have small renal tumors are more likely to undergo radical nephrectomy of the affected kidney than partial nephrectomy, according to a retrospective study presented at the 2008 Genitourinary Cancers Symposium (abstract 387).

Most older men with early-stage cancer can avoid treatment

March 02, 2008

Most older men with early-stage prostate cancer will not require treatment or will die of other causes before their cancer progresses significantly, according to a retrospective study of 9,018 men from the SEER database. The men had been diagnosed with stage I-II disease between 1992 and 2002 and did not receive local therapy initially or hormonal therapy within 6 months of diagnosis.

SERM reduces ADT side effects

March 02, 2008

Toremifene citrate (Acapodene) 80 mg reduced the occurrence of vertebral fractures and met other key endpoints in a phase III trial of 1,389 men receiving androgen deprivation therapy for advanced prostate cancer, GTx, Inc. said in a press release. Based on these findings, the company plans to file a New Drug Application with FDA by the summer of this year for the treatment of multiple side effects of ADT.

New serum biomarker appears to detect colon cancer

March 02, 2008

A serum marker, colon-cancer-specific antigen-2 (CCSA-2), detects nearly 97% of colorectal cancers and can differentiate between advanced adenomatous polyps and less ominous ones, according to investigators from Johns Hopkins and the University of Pittsburgh who have collaborated on research in this area.

Surface mapping aligns patients for external beam PBI

March 02, 2008

When positioning patients for external beam partial breast irradiation (PBI), body surface mapping is more accurate than either alignment using lasers or alignment using kilovoltage (kV) on-board imaging, a new study shows.

Is benefit of trastuzumab limited to first 18 months?

March 02, 2008

Four-year follow-up of the French/Belgian PACS-04 trial in early breast cancer found a trend toward benefit with sequential trastuzumab (Herceptin) in the first 18 months but, somewhat surprisingly, no difference in disease-free survival at 4 years. Marc Spielmann, MD, of the Institute Gustave Roussy, Villejuif, France, reported the findings at the 2007 San Antonio Breast Cancer Symposium (abstract 72).

Dual seed/wafer implants promising in recurrent GBM

March 01, 2008

In a small study, patients with recurrent glioblastoma multiforme who received dual implantation of low-activity iodine-125 seeds and wafers containing carmustine (Gliadel) following surgery had a median survival of 69 weeks, with nearly one-fourth of patients (8 of 34) surviving 2 years.

Company asks for new survival data on Eloxatin label

March 01, 2008

Sanofi-aventis’ supplemental New Drug Application for Eloxatin (oxaliplatin) has been accepted by FDA and assigned priority review status. The sNDA proposes changes to the Eloxatin prescribing information to include long-term survival data from the MOSAIC trial.

Low toxicity with SAVI breast brachytherapy

March 01, 2008

Using the SAVI applicator for breast brachytherapy, 14 of 18 patients experienced no skin reactions, and the other four had only minor reactions that resolved quickly, Constantine Mantz, MD, reported at the 25th Annual Miami Breast Cancer Conference. Dr. Mantz, a radiation oncologist at 21st Century Oncology, Inc. Fort Myers, Florida, said that the overall cosmetic outcomes with SAVI were rated excellent.

Sunitinib shows activity in heavily pretreated NSCLC patients

March 01, 2008

In a phase II, multicenter trial, sunitinib (Sutent) showed activity as a single agent in heavily pretreated non-small-cell lung cancer patients. The overall objective response rate was 11.1%, and median overall survival was 23.4 weeks (Socinski et al: J Clin Oncol 26:650-656, 2008).

New study may restore faith in CAD mammography

March 01, 2008

A new study based on nearly a quarter million mammograms suggests screening mammography with computer-aided detection is more sensitive than double reads. The findings contradict a key study published last year questioning CAD's effectiveness. CAD's potential for yielding too many false positives remains controversial. Radiologists argue its misuse drives up recall rates and, with them, the number of unwarranted biopsies and overall mammography costs.

Chelation therapy ups survival in low-risk MDS patients

March 01, 2008

In patients with low- and intermediate-risk myelodysplastic syndromes (MDS) who have regularly received transfusions, chelation therapy improves survival, according to a study presented at ASH 2007 (abstract 249).

Pfizer to acquire Serenex

March 01, 2008

Pfizer Inc. has entered into an agreement to acquire Serenex, Inc., a privately held biotechnology company with an extensive compound library that targets Heat Shock Protein 90 (Hsp90). Pfizer will acquire the rights to SNX-5422, an oral Hsp90 inhibitor currently in phase I trials for the treatment of solid tumors and hematological malignancies.

Diagnostic Dilemma: GI Disease

March 01, 2008

An 85-year-old woman presented to the emergency department with epigastric pain and nausea for 2 days. She denied vomiting, fever, or early satiety. The patient stated she had lost 10 pounds over the past 3 months. A CT scan of the abdomen revealed a 1 cm low attenuation lesion in the second portion of the duodenum.

Herceptin and Tykerb going head-to-head

March 01, 2008

In one of the most ambitious clinical trial efforts to date, a phase III study involving 8,000 participants in 50 countries across six continents will provide a head-to-head comparison of trastuzumab (Herceptin) and lapatinib (Tykerb) in HER2-positive patients with early-stage breast cancer who have recently completed chemotherapy.

The long and winding road to Houston

March 01, 2008

Gabriel N. Hortobagyi, MD, was born in Hungary to a mother who had wanted to be physician. “It was a time and place in which medicine was not a suitable profession for a woman, yet I think my mother’s subliminal messages worked on me,” he said in an interview with Oncology News International.

Less ESA use, more transfusions

March 01, 2008

A recent national survey found a striking increase in adverse events among Medicare cancer patients directly related to CMS’ national coverage decision on the use of erythropoiesis-stimulating agents.

Do oncologists treat patients as they would themselves?

March 01, 2008

Do oncologists treat their patients with colon cancer the same as they would treat themselves? Usually. A survey presented at the 2008 Gastrointestinal Cancers Symposium probed the secret world of oncologists' personal preferences (abstract 444).

Host HSC depletion improves donor engraftment in mice

March 01, 2008

A novel approach aimed at depleting host hematopoietic stem cells (HSCs) by an immunologic method may facilitate subsequent donor stem cell transplantation without the need for traditional myeloablative conditioning regimens. Agnieszka Czechowicz, a medical student conducting research in the laboratory of Irving Weissman, MD, at Stanford, discussed results of her research using murine transplantation models that could reduce the toxicity associated with traditional approaches and expand the potential applications for HSC transplantation (ASH 2007, abstract LB2).

Initial results: Amifostine fails to reduce acute toxicity in cervical ca pts on CT-RT

March 01, 2008

The cytoprotective agent amifostine (Ethyol) did not reduce the rate of acute severe toxicity among patients undergoing combined radiation therapy and chemotherapy for locally advanced cervical cancer, according to a phase I/II study reported at ASTRO 2007 (abstract 10). The trial, RTOG 0116, enrolled women with cervical cancer who had evidence of positive para-aortic or high common iliac nodes.

Emerging technology detects occult lymph node mets in colon ca

March 01, 2008

Accurate detection of micrometastases in the lymph nodes of colorectal cancer patients appears possible with an emerging quantitative RT-PCR assay being developed by DiagnoCure Oncology Laboratories (West Chester, Pennsylvania), according to an interview with investigators at the 2008 Gastrointestinal Cancers Symposium. Data from a large prospective NIH-sponsored trial are expected to be reported at ASCO 2008.

A better way to improve colon ca prognosis?

March 01, 2008

Survival and staging in colon cancer are related to the number of lymph nodes containing metastasis. But according to several reports from the 2008 Gastrointestinal Cancers Symposium, there may be a better way to determine prognosis. The “index of metastasis,” also called the “lymph node ratio,” may be a more accurate predictor of cancer-related survival than the number of positive nodes, according to investigators who presented data at the meeting.

New assay measures HER2 expression more precisely

March 01, 2008

The HER2-positive breast cancer population appears to be a heterogeneous group with a wide variation in response to trastuzumab (Herceptin). Higher levels of HER2 expression as well as HER2:HER2 dimerization were independently correlated with high response rates and longer time to progression in a study reported at the 2007 San Antonio Breast Cancer Symposium (abstract 2007).

RAD001 increases letrozole’s anti-breast cancer activity

March 01, 2008

In the neoadju-vant setting, adding the investigational agent RAD001 (everolimus) to letrozole (Femara) improves antitumor activity in breast cancer patients, with a tradeoff of some increased toxicity, according to results presented at the San Antonio Breast Cancer Symposium (abstract 2066).

Method helps standardize RT dose reporting

March 01, 2008

A new method for converting between different definitions of lung volume may help standardize radiation dose reporting for patients receiving radiation therapy for lung cancer, finds a study using four-dimensional CT imaging. 4D-CT is a series of CT scans that measure how much a tumor moves when a patient breathes and allows radiation oncologists to personalize radiation treatment for this motion.

Gemcitabine active as adjuvant Rx for pancreatic head ca

March 01, 2008

Last month, ONI reported evidence from two retrospective studies and one phase II trial for the use of adjuvant chemoradiation in resected pancreatic cancer patients (Feb. 2008, pages 1 and 31). Now, RTOG investigators report a strong trend toward improved survival in patients with resected cancer of the pancreatic head with gemcitabine (Gemzar) plus fluorouracil (5-FU)-based chemoradiation, compared with standard 5-FU chemoradiation (JAMA 299:1019-1026, 2008).

Azacitidine ups overall survival in high-risk MDS patients

March 01, 2008

Results of a phase III trial show for the first time a significant survival advantage in patients with high-risk myelodysplastic syndrome who were treated with the DNA methylation inhibitor azacitidine (Vidaza). Pierre Fenaux, MD, of the Hôpital Avicenne, Bobigny, France, presented these findings on behalf of the International Vidaza High-Risk MDS Survival Study Group at ASH 2007 (abstract 817).

New ‘VISTA’ opens for newly diagnosed myeloma pts

March 01, 2008

Phase III study results show that addition of the proteosome inhibitor bortezomib (Velcade) to standard chemotherapy significantly improves outcomes in patients with newly diagnosed multiple myeloma who are not eligible for high-dose chemotherapy and stem-cell transplantation (SCT).

Pooled results confirm Len/Dex benefits in myeloma

March 01, 2008

Multiple myeloma patients receiving lenalidomide (Revlimid) plus dexamethasone had improved responses, longer time to progression, and improved overall survival than those receiving dexamethasone alone in pooled phase III clinical trial results. Donna Weber, MD, of M.D. Anderson Cancer Center, presented the findings at ASH 2007 (abstract 412).

Salvage RT increases survival in recurrent prostate ca

March 01, 2008

Providing radiation therapy for prostate cancer patients who have rising PSA levels after radical prostatectomy reduced the risk of dying from prostate cancer by more than 60% at 10 years, according to a retrospective study of patients treated at Johns Hopkins.