ASCO Innovations in Cancer Care

The 2010 Annual Meeting of the American Society of Clinical Oncology (ASCO), held June 4 to 8 in Chicago, brought together an estimated 30,000 oncology specialists. The studies presented at the meeting addressed topics ranging from prevention and early detection through treatment and survivorship.

Yoga Improves Sleep and Quality of Life

Sleep problems and fatigue are among the most common problems experienced by cancer survivors and can have a profound impact on quality of life. Sleep problems are very common during cancer treatment but can persist even after treatment ends.

To evaluate the impact of a yoga program on sleep and fatigue, researchers at the University of Rochester conducted a study among 410 survivors of early-stage cancers who reported sleep problems after completion of cancer treatment.1

Study participants were assigned to receive either usual care or usual care plus a four-week, twice-weekly YOCAS® (Yoga for Cancer Survivors) program. The YOCAS program consisted of mindfulness exercises such as breathing, meditation, visualization, and poses in standing, seated, and reclining positions.

Compared with patients who received usual care alone, patients in the yoga program reported greater sleep quality, less use of drugs for sleep, less fatigue, and better quality of life.

Promising Results for Ovarian Cancer Screening Strategy

Roughly 70 percent of ovarian cancers are diagnosed at an advanced stage, highlighting the importance of developing an ovarian cancer screening strategy that accurately identifies cancer at an early, more treatable stage. Currently, however, there are no ovarian cancer screening tests that are routinely used in women at average risk of the disease.

An investigational ovarian cancer screening strategy that was presented at ASCO is called ROCA (Risk of Ovarian Cancer Algorithm).2 It uses a mathematical model to combine information about patient age and changes in CA-125 levels over time. Based on the results, women are placed in one of three categories:

Low risk (repeat CA-125 test in one year)

Intermediate risk (repeat CA-125 test in three months)

High risk (transvaginal ultrasound and referral to a gynecologic oncologist; based on clinical findings and ultrasound result, the gynecologic oncologist decides whether to proceed to surgery)

This screening strategy was evaluated in 3,238 postmenopausal women between the ages of 50 and 74. Study participants had no significant history of breast or ovarian cancer and were followed for up to eight years.

Each year less than 1 percent of women required a transvaginal ultrasound.

Over the course of the study, a total of 85 women (2.6 percent) received transvaginal ultrasound and a referral to a gynecologic oncologist.

Eight women underwent surgery. Three had invasive but early-stage ovarian cancer, two had borderline ovarian tumors, and three had benign ovarian tumors.

Overall, the screening strategy was feasible, had a low rate of false-positive results, and was able to identify some women with early ovarian cancer. The test is being further evaluated in a large study in the United Kingdom.

Avastin Delays Progression of Advanced Ovarian Cancer

Avastin® (bevacizumab) is a targeted therapy that blocks a protein known as the vascular endothelial growth factor (VEGF). VEGF plays an important role in the development of new blood vessels. By blocking VEGF, Avastin deprives the cancer of nutrients and oxygen and inhibits its growth. Avastin has been approved for the treatment of selected patients with breast cancer, lung cancer, colorectal cancer, kidney cancer, or glioblastoma.

To evaluate the combination of Avastin and chemotherapy among women with ovarian cancer, researchers conducted a Phase III clinical trial among 1,873 women with newly diagnosed, advanced epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.3

After surgery to remove as much of the cancer as possible, study participants were assigned to one of three treatment groups:

Chemotherapy alone

Chemotherapy plus Avastin with no maintenance therapy

Chemotherapy plus Avastin followed by up to 10 months of Avastin maintenance therapy

Progression-free survival was 14.1 months among patients treated with chemotherapy plus Avastin followed by Avastin maintenance therapy, 11.2 months among patients treated with chemotherapy plus Avastin but no maintenance therapy, and 10.3 months among patients treated with chemotherapy alone. Side effects of Avastin included high blood pressure and low white blood cell counts.

These results suggest that Avastin slows cancer progression among women with advanced ovarian, primary peritoneal, or fallopian tube cancer. The best outcomes were observed among women who received Avastin maintenance therapy after treatment with chemotherapy and Avastin.

Lumpectomy Without Radiation an Option for Some Older Breast Cancer Patients

After lumpectomy for early breast cancer, women often receive several weeks of radiation therapy to reduce the risk of cancer recurrence. Recent research, however, suggests that some older women may be able to safely forgo radiation therapy.

The study involved 636 women aged 70 or older with Stage I, estrogen receptor–positive breast cancer.4 After lumpectomy, women were assigned to additional treatment with tamoxifen (Nolvadex®) alone or tamoxifen plus radiation therapy. Women have now been followed for more than 10 years.

The risk of cancer recurrence in the same breast was lower among women who received radiation therapy: a local cancer recurrence developed in 2 percent of women treated with tamoxifen and radiation therapy and 8 percent of women treated with tamoxifen alone.

Breast cancer–specific and overall survival were similar in the two study groups.

These results suggest that among older women treated with lumpectomy and tamoxifen for Stage I, estrogen receptor–positive breast cancer, skipping radiation therapy increases the risk of local cancer recurrence but does not adversely affect overall survival.

Ipilimumab Improves Outcomes in Advanced Melanoma

Melanoma is the most deadly type of skin cancer. Each year in the United States, there are roughly 68,000 new diagnoses of melanoma and 8,700 deaths from the disease.5 Finding effective treatments for advanced melanoma has been challenging, and research in this area continues.

Ipilimumab is an investigational drug that targets a molecule known as CTLA4, which is found on the surface of T-cells and is thought to inhibit immune responses. By targeting this molecule, ipilimumab may enhance the immune system’s response against tumor cells.

To evaluate ipilimumab in the treatment of melanoma, researchers conducted an international Phase III clinical trial among 676 patients with previously treated, Stage III or Stage IV melanoma.6

Patients were assigned to one of three treatment groups:

Ipilimumab

Ipilimumab plus the gp100 vaccine

The gp100 vaccine alone

The gp100 vaccine is an experimental melanoma vaccine that is also designed to stimulate T-cells to attack melanoma cells. In previous studies it has shown modest anticancer activity and was superior to treatment with IL-2.

Median overall survival was 10 months in the groups that received ipilimumab compared with 6.5 months in the group that received the gp100 vaccine alone.

Two-year survival was 24 percent among patients who received ipilimumab alone, 22 percent among those who received ipilimumab and the gp100 vaccine, and 14 percent among those who received the gp100 vaccine alone.

Six-month progression-free survival was 30 percent among patients in the ipilimumab groups and 11 percent among patients in the group that received the gp100 vaccine alone.

Ipilimumab was generally well tolerated, but 10 to 14 percent of patients treated with ipilimumab experienced sometimes-severe side effects such as rash and colitis (inflammation of the colon). The frequency among patients treated with gp100 was roughly 3 percent.

These results suggest that ipilimumab may delay cancer progression and improve overall survival among patients with previously treated, advanced melanoma. The addition of the gp100 vaccine to ipilimumab did not appear to further improve outcomes.

Sprycel May Be More Effective Than Gleevec for Initial Treatment of CML

Most cases of chronic myeloid leukemia (CML) are characterized by a chromosomal abnormality—the Philadelphia chromosome—in which genetic material is exchanged between chromosome 9 and chromosome 22. This exchange brings together two genes: BCR and ABL. The combination of these two genes into the single BCR-ABL gene results in the production of a protein that contributes to uncontrolled cell growth.

Recognition of the pivotal role of the BCR-ABL protein in CML led to the development of Gleevec® (imatinibmesylate), which blocks the activity of this protein. Gleevec produces high rates of remission among patients with chronic-phase CML, often with few side effects, and has dramatically changed the treatment of this disease.7

Sprycel® (dasatinib) also targets the BRC-ABL protein and has provided an important option for patients who are resistant to or intolerant of Gleevec. Sprycel has not yet been approved for the initial treatment of CML.

To compare Gleevec and Sprycel for the initial treatment of CML, researchers conducted a study among 519 patients with newly diagnosed, Philadelphia chromosome–positive, chronic-phase CML.8 Patients were assigned to receive either Gleevec or Sprycel.

After one year the complete cytogenetic response rate was 77 percent among patients treated with Sprycel and 66 percent among patients treated with Gleevec.

Rates of major molecular response were 46 percent among patients treated with Sprycel and 28 percent among patients treated with Gleevec.

Both drugs were generally well tolerated.

These results suggest that Sprycel may be more effective than Gleevec for the initial treatment of CML. Researchers will continue to follow the study participants to determine whether there are differences between groups in progression-free and overall survival.

Combination Chemotherapy Improves Survival in Elderly Lung Cancer Patients

Lung cancer remains the leading cause of cancer death in the United States. Non–small cell lung cancer (NSCLC) accounts for approximately 85 percent of all lung cancers.

Although people age 70 or older account for at least 30 percent of NSCLC cases, there is limited information about how best to treat older patients. As a result of the limited information and concern that elderly patients will not be able to tolerate aggressive treatment, older patients may be treated with single-agent chemotherapy rather than combination chemotherapy.

To explore treatment options for older patients with advanced NSCLC, researchers in France conducted a Phase III clinical trial in 451 patients between the ages of 70 and 89.9 Patients were assigned to receive either combination chemotherapy with Taxol® (paclitaxel) and Paraplatin® (carboplatin) or single-agent chemotherapy with Gemzar® (gemcitabine) or Navelbine® (vinorelbine).

Overall survival was 10.4 months among patients treated with combination chemotherapy and 6.2 months among patients treated with single-agent chemotherapy.

Survival without cancer progression was 6.3 months among patients treated with combination chemotherapy and 3.2 months among patients treated with single-agent chemotherapy.

Combination chemotherapy had acceptable toxicity but did increase the likelihood of moderate to severe neutropenia (low white blood cell count).

These results suggest that older patients with advanced NSCLC can be considered for the same aggressive therapy as younger patients.

Taken together, these and other studies presented at ASCO highlight the gradual but important progress that is being made in cancer detection and treatment.

References

1. Mustian KM, Palesh O, Sprod L, et al. Effect of YOCAS yoga on sleep, fatigue, and quality of life: a URCC CCOP randomized, controlled clinical trial among 410 cancer survivors. Paper presented at: 46th Annual Meeting of the American Society of Clinical Oncology; June 4-8, 2010; Chicago, Illinois. Abstract 9013.

2. Lu KH, Skates S, Bevers TB, et al. A prospective U.S. ovarian cancer screening study using the risk of ovarian cancer algorithm (ROCA). Paper presented at: 46th Annual Meeting of the American Society of Clinical Oncology; June 4-8, 2010; Chicago, Illinois. Abstract 5003.

3. Burger RA, Brady MF, Bookman MA, et al. Phase III trial of bevacizumab (BEV) in the primary treatment of advanced epithelial ovarian cancer (EOC), primary peritoneal cancer (PPC) or fallopian tube cancer (FTC): a Gynecologic Oncology Group study. Paper presented at: 46th Annual Meeting of the American Society of Clinical Oncology; June 4-8, 2010; Chicago, Illinois. Abstract LBA 1.

4. Hughes KS, Schnaper LA, Cirrincione C, et al. Lumpectomy plus tamoxifen with or without irradiation in women age 70 or older with early breast cancer. Paper presented at: 46th Annual Meeting of the American Society of Clinical Oncology; June 4-8, 2010; Chicago, Illinois. Abstract 507.

5. Cancer Facts & Figures 2010. American Cancer Society Web site. Available at: http://www.cancer.org/docroot/stt/stt_0.asp. Accessed June 16, 2010.

6. O’Day S, Hodi FS, McDermott DF, et al. A phase III, randomized, double-blind, multicenter study comparing monotherapy with ipilimumab or gp100 peptide vaccine and the combination in patients with previously treated, unresectable stage III or IV melanoma. Paper presented at: 46th Annual Meeting of the American Society of Clinical Oncology; June 4-8, 2010; Chicago, Illinois. Abstract 4.

7. Pinilla-Ibarz J, Quintas-Cardama A. New agents in the treatment of chronic myelogenous leukemia. Journal of the National Comprehensive Cancer Network. 2009;7:1028-37.

8. Kantarjian H, Shah NP, Hochhaus A, et al. Dasatinib compared to imatinib in patients with newly diagnosed chronic-phase chronic myelogenous leukemia in chronic phase (CML-CP): 12 month efficacy and safety from the phase 3 DASISION study. Paper presented at: 46th Annual Meeting of the American Society of Clinical Oncology; June 4-8, 2010; Chicago, Illinois. Abstract LBA 6500.

9. Quoix EA, Oster J, Westeel V, et al. Weekly paclitaxel combined with monthly carboplatin versus single agent therapy in patients aged 70 to 89: IFCT-0501 randomized phase III study in advanced non-small cell lung cancer (NSCLC). Paper presented at: 46th Annual Meeting of the American Society of Clinical Oncology; June 4-8, 2010; Chicago, Illinois. Abstract 2.