Study Confirms Adding Chemotherapy To Surgery Improves Survival In Advanced Gastric Cancer

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References

1. Abstracts from the 15th ESMO World Congress on Gastrointestinal Cancer are published in Annals of Oncology, Volume 24 suppls 4 June 2013 (Ann Oncol 2013 Jun; 24(Suppl 4): 5-130) http://annonc.oxfordjournals.org/content/24/suppl_4.toc

2. Abstract presentation: Thursday, 4 July 2013, 17:25 hrs, Session VII: Gastric Cancer About the ESMO World Congress on Gastrointestinal Cancer The ESMO World Congress on Gastrointestinal Cancer is the premier global event in the field, encompassing malignancies affecting every component of the gastrointestinal tract and aspects related to the care of patients with gastrointestinal cancer, including screening, diagnosis and the latest management options for common and uncommon tumours. It has been endorsed by leading professional societies and organizations.
The ESMO 15th World Congress on Gastrointestinal Cancer has been organized in partnership with ESMO (European Society for Medical Oncology). The Congress is developed and managed by ImedexR, LLC.

ABSTRACT 0007

Adjuvant capecitabine and oxaliplatin (XELOX) for gastric cancer after D2 gastrectomy: final results from the CLASSIC trial
Sung Hoon Noh 1, Sook Ryun Park 2, Han-Kwang Yang 3, Hyun Cheol Chung 1, Ik-Joo Chung 4, Kyung Hee Lee 5, Hyung-Ho Kim 6, Jiafu Ji 7, Jen-Shi Chen 8, Yunni Lim 9, Stella Ha 9, Yung-Jue Bang 3

1 Yonsei University College of Medicine, Seodeamungyu Shinchon-dong 134, Seoul, 2 Research Institute and Hospital, National Cancer Center, Ilsandong-gu, Goyang-si Gyeonggi-do, 3 Seoul National University College of Medicine, Jongno-gu, Seoul, 4 Chonnam National University Hwasun Hospital, Hwasun-Eup, Hwasun-Gun, Jeonnam, 5 Yeungnam University College of Medicine, Nam-gu, Daegu, 6 Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, 7 Beijing Cancer Hospital, Haidian, Beijing, 8 Chang Gung Memorial Hospital, Kwei-Shan Shiang, Taoyuan, 9 Roche Korea Co.,Ltd, Seocho-Gu, Seoul

Background: D2 gastrectomy, which is widely used in East Asia as the preferred surgery for patients with operable gastric cancer, is now recommended in US and European treatment guidelines for gastric cancer. Two phase III trials (ACTS-GC and CLASSIC) have been performed to assess the possible benefits of adjuvant chemotherapy after D2 surgery. ACTS-GC showed a survival benefit with fluoropyrimidine monotherapy after D2 gastrectomy compared with surgery only [Sasako et al. J Clin Oncol 2011;29:4387–93]. The CLASSIC trial compared fluoropyrimidine-oxaliplatin combination therapy (XELOX) with surgery alone; interim results showed that XELOX improved 3-year disease-free survival after D2 gastrectomy compared with surgery only [Bang et al. Lancet 2012;379:315–21]. Improved overall survival was also evident after only 3 years, but the data were immature. We report here the final results from the CLASSIC trial after a median follow-up of 5 years.

Methods: CLASSIC was a multinational open-label randomised phase III trial performed in South Korea, China, and Taiwan. Randomisation was stratified by country and disease stage. Patients with stage II–IIIB gastric cancer who had undergone curative D2 gastrectomy were assigned to adjuvant XELOX (oxaliplatin 130 mg/m2 day 1 plus capecitabine 1000 mg/m2 twice daily days 1-14 q3w) for 8 cycles or surgery alone. The primary endpoint was 3-year disease-free survival. The clinical cut-off date for the prospectively planned final 5-year efficacy analysis was 22 November 2012.

Results: At data cut-off, 103 (20%) patients in the XELOX group and 141 (27%) patients in the surgery alone group had died. This represented a 34% reduction in the risk of death with XELOX versus surgery alone (hazard ratio 0.66, 95% CI 0.51–0.85; p=0.0015 by stratified Cox regression analysis). The 5-year overall survival rate was 78% in the XELOX group and 69% in the surgery alone group (p=0.0029, log-rank test unstratified). 76 (15%) patients in the XELOX group and 135 (26%) patients in the surgery alone group received subsequent, non-protocol-specified anticancer therapies after progression of disease. In the analysis of disease-free survival, 139 (26.7%) patients in the XELOX group and 203 (39.4%) patients in the surgery alone group had relapsed, developed a new gastric cancer or died. This represented a 42% reduction in the risk of an event with XELOX versus surgery alone (hazard ratio 0.58, 95% CI 0.47–0.72; p<0.0001 by stratified Cox regression analysis). The 5-year disease-free survival rate was 68% in the XELOX group and 53% in the surgery alone group (p<0.0001, log-rank test unstratified).

Conclusion: The final analysis of the CLASSIC trial, after a median follow-up of 5 years, supports the findings from the primary analysis performed 2 years earlier. Adjuvant XELOX after curative D2 gastrectomy improves overall survival compared with surgery alone and should be considered as a standard treatment option for patients with operable gastric cancer.

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Additional Evidence That Post-Lumpectomy Radiation Improves Breast Cancer Outcomes

?In addition to reducing the risk of breast cancer recurrence, post-lumpectomy radiation therapy improves survival among women with early breast cancer. These results—from a combined analysis of 17 previous studies—were published in The Lancet.?????

Surgery for early-stage breast cancer may consist of mastectomy or lumpectomy. A?mastectomy?involves removal of the entire breast, whereas a?lumpectomy?involves removal of the cancer and some surrounding tissue. A lumpectomy is usually followed by radiation therapy in order to reduce the risk of cancer recurrence in or near the breast. The combination of lumpectomy and radiation therapy is referred to as breast-conserving therapy.???

Several previous studies have reported giving radiation therapy after lumpectomy results in a lower risk of breast cancer recurrence than lumpectomy alone. To further evaluate the benefits of post-lumpectomy radiation therapy, researchers conducted a combined analysis of 17 previous studies. These studies included more than 10,000 women with early-stage breast cancer.???

Post-lumpectomy radiation therapy reduced the 10-year risk of breast cancer recurrence from 35% to 19%. ?The 15-year risk of death from breast cancer was 25% among women who did not receive post-lumpectomy radiation therapy and 21% among women who did receive radiation therapy. ?For every four breast cancer recurrences that were prevented by radiation therapy by year 10, one breast cancer death was prevented by year 15.?Benefits of radiation therapy were seen in women with node-negative breast cancer as well as women with node-positive breast cancer.?

These results provide additional evidence that giving radiation therapy after a lumpectomy substantially reduces the risk of cancer recurrence and also reduces the risk of death from breast cancer.?????

Reference: Early Breast Cancer Trialists’ Collaborative Group. Effect of radiotherapy after breast-conserving surgery on 10-year recurrence and 15-year breast cancer death: meta-analysis of individual patient data for 10,801 women in 17 randomised trials. Lancet. Early online publication October 20, 2011.?

Posted October 27, 2011?

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Halaven Improves Survival with Metastatic Breast Cancer

Among women with previously treated, locally recurrent or metastatic breast cancer, treatment with the chemotherapy drug Halaven? (eribulin mesylate) improved overall survival by 2.5 months. The results of this Phase III clinical trial were published in The Lancet.

Metastatic breast cancer refers to cancer that has spread to distant sites in the body. Treatment of metastatic breast cancer often includes chemotherapy, but options can become limited when the cancer stops responding to conventional chemotherapy regimens.

Halaven—which was derived from a marine sponge—is a chemotherapy drug that affects cell division. It was approved by the U.S. Food and Drug Administration (FDA) in November, 2010.

The EMBRACE study is a Phase III clinical trial that contributed to approval of Halaven. The study enrolled 762 patients with locally recurrent or metastatic breast cancer. All of the women had received between two and five previous chemotherapy regimens. These previous regimens must have included an anthracycline and a taxane.

Study participants were assigned to receive either Halaven or “treatment of physician’s choice.” Because there is no single standard treatment regimen for women at this stage of breast cancer, treatment of women in the comparison group was left up to the patient’s physician.

Median overall survival was 13.1 months among women treated with Halaven, compared with 10.6 months among women treated with physician’s choice.Progression-free survival and response rates also favored Halaven.Halaven was generally well tolerated.?

The results of this study suggest that Halaven can extend life among women with advanced, heavily pretreated breast cancer.

Reference: Cortes J, O’Shaughnessy J, Loesch et al. Eribulin monotherapy versus treatment of physician’s choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study. The Lancet. Early online publication March 3, 2011.

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Combined HER2 Treatment Improves Outcome of Advanced Breast Cancer

Among women with metastatic, HER2-positive breast cancer, treatment with a combination of HER2-targeted therapies may produce better outcomes than treatment with only a single HER2-targeted therapy. These results were published in the New England Journal of Medicine and were also presented at the 2011 CTRC-AACR San Antonio Breast Cancer Symposium.????

Approximately 20-25% of breast cancers overexpress (make too much of) a protein known as HER2. Fortunately, the development of drugs that specifically target HER2-positive breast cancer has improved outcomes. These drugs include HerceptinR (trastuzumab), TykerbR (lapatinib), and the investigational drug pertuzumab.????

To explore whether treatment with both Herceptin and pertuzumab can improve outcomes among women with metastatic, HER2-positive breast cancer, researchers conducted a study among 808 patients. All patients received Herceptin and chemotherapy, and some patients also received pertuzumab.????

The addition of pertuzumab delayed cancer progression. Survival without cancer progression was 12.4 months among patients treated with only Herceptin and chemotherapy, and 18.5 months among patients treated with Herceptin, chemotherapy, and pertuzumab.?The addition of pertuzumab was generally well tolerated by patients, although patients in the pertuzumab group were more likely to experience febrile neutropenia (low-white blood cell count accompanied by fever) and diarrhea.?

These results suggest adding pertuzumab to Herceptin and chemotherapy may improve outcomes among women with metastatic, HER2-positive breast cancer.?

Studies are also exploring the use of pertuzumab in early-stage breast cancer.?

Reference: Baselga J, Cortes J, Kim S-B. Pertuzumab plus trastuzumab plus doxetaxel for metastatic breast cancer. New England Journal of Medicine. Early online publication December 7, 2011.?

Posted December 13, 2011?

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