A common feature in many of these trials has been the use of a taxane, and more recently, a taxane combined with an antimetabolite. If time to recurrence is several years following adjuvant therapy, retreatment with prior active agents may be desirable. Response rates of 15%–26% were demonstrated, with a median survival time of approximately 1 year. The addition of bevacizumab produced a significantly higher overall response rate; however, there were no differences in median progression‐free or overall survival times. The first of those trials compared the combination of docetaxel (75 mg/m2) and capecitabine (2,500 mg/m2) with docetaxel alone (100 mg/m2) in 511 patients with disease progression or recurrence following anthracycline‐based chemotherapy (Table 3) [24]. Capecitabine demonstrated a favorable safety profile in those trials, with predominant adverse events of cutaneous and gastrointestinal events. Or try an online message board for cancer survivors, such as the American Cancer Society's Cancer Survivors … A prognostic eight‐gene expression signature for patients with breast cancer receiving adjuvant chemotherapy. In a multivariate model that factored in significant prognostic factors, however, this difference was found to be significant (p = .025). Interestingly, there were no statistically significant differences in global QoL scores (as assessed by the Functional Assessment of Cancer Therapy tool) between treatment groups over time, suggesting that toxicity differences did not affect QoL. Docetaxel was associated with more toxicities than paclitaxel, including grade 3–4 neutropenia, asthenia, edema, infection, and stomatitis. Prevalence and characteristics of patients with metastatic cancer who receive no anticancer therapy. Combination therapy produced a significantly higher overall response rate and longer time to treatment failure than either single agent arm; however, there were no differences in overall survival times among the three arms (Table 1). There is no single standard of care for patients with MBC, as treatment plans require an individualized approach based on multiple factors. The consequent hyperpermeable, irregular vessels cause irregular blood flow and high interstitial fluid pressure within the tumor, which can impair the delivery of oxygen (a known radiation sensitizer) and drugs to the tumor site. Combination therapies are associated with higher overall response rates, albeit at a cost of greater toxicities. In addition, patients who received trastuzumab had a significant improvement in global QoL scores (p < .05). The median overall survival time with the combination was 18.5 months, 2.7 months higher than that seen with single‐agent paclitaxel. An additional phase III trial compared single‐agent paclitaxel (200 mg/m2) with the alkylating agent–based combination of cyclophosphamide, methotrexate, fluorouracil, and prednisone (Deltasone®; Pfizer Pharmaceuticals) (CMFP) in 209 patients as first‐line therapy for metastatic disease [27]. The role of the taxanes, antimetabolites, and biologics in extending survival in MBC is discussed. I forgot about being a cancer patient and all the guests assumed I was the “fun” chick in the wigs. If you do not receive an email within 10 minutes, your email address may not be registered, The overall response rate and time to disease progression were significantly greater for patients randomized to doxorubicin than for those given paclitaxel, but there was no statistical difference in overall survival time between groups (Table 4). We report the data for the secondary end point of disease-free survival … So, I resigned myself to the fact that I was NOT going to miss them. Both the trastuzumab–taxane randomized trials demonstrated that overall survival is optimized in HER‐2–positive MBC patients by beginning trastuzumab along with the first chemotherapy regimen given for MBC rather than giving trastuzumab following first‐line chemotherapy. Overall QoL measures were similar in the two treatment arms. A study by Statistics are not available for survival rates by cancer stage. Let me explain. First of all, chemo is a drag. Late effects of cancer treatment can come from any of the main types of cancer treatment: chemotherapy, hormone therapy, radiation, surgery, targeted therapy and immunotherapy. MBC remains essentially incurable, and current goals of therapy are to ameliorate symptoms, delay disease progression, improve or at least maintain quality of life (QoL), and prolong overall survival. Overexpression of HER‐2 is associated with clinically aggressive disease and a shorter survival time. Breast cancer as a systemic disease: a view of metastasis. Taxane‐based therapy is often considered for patients with anthracycline‐pretreated breast cancer; however, it is becoming increasingly common for patients to have received both an anthracycline and a taxane in the adjuvant setting. Epirubicin/paclitaxel (ET) vs epirubicin/cyclophosphamide (EC). Capecitabine in Combination with Novel Targeted Agents in the Management of Metastatic Breast Cancer: Underlying Rationale and Results of Clinical Trials, https://doi.org/10.1634/theoncologist.10-90003-20. Overall survival also favored the addition of bevacizumab, but median values had not yet been reached. A QoL analysis was conducted, and though interpretation of the results was limited, there were no apparent differences in QoL between treatment groups. In addition, there is a small but growing number of randomized clinical trials reporting statistically significant survival improvements in women with MBC [14, 15, 22–30]. This means 90 out of 100 women are alive 5 years after they’ve been diagnosed with … Stage I and II breast cancers. The relative benefits and toxicities of individual agents or combinations must be considered as well as the treatment history and clinical status of the patient. Leukopenia, thrombocytopenia, nausea and vomiting, and mucositis occurred more frequently with CMFP. As the risk for congestive heart failure is much greater when trastuzumab is given with doxorubicin, this combination is generally avoided [14]. Although grade 4 neutropenia was more common with the combination, overall toxicities in both arms were manageable. With targeted biologics, such as trastuzumab and bevacizumab, the potential for enhanced or synergistic activity is a compelling argument for the use of these agents in combination with traditional chemotherapeutics. Prior adjuvant chemotherapy was permitted. A QoL analysis showed no differences in global health scores between the two arms after the third cycle of therapy. Yes. And aside from the E1193 trial, well‐defined comparisons of combination regimens with the same agents in sequence are not available, and the ultimate impact on survival outcomes between the two approaches remains to be seen. The NCDB does not provide breast cancer–specific survival data, and OS might not be an appropriate surrogate in elderly patients with breast cancer with increased life expectancy rates. It’s hard but know that you can do it. In addition, capecitabine (Xeloda®; Hoffmann‐La Roche Inc., Nutley, NJ, http://www.rocheusa.com), gemcitabine (Gemzar®; Eli Lilly and Company, Indianapolis, http://www.lilly.com), and vinorelbine (Navelbine®; GlaxoSmithKline, Philadelphia, http://www.gsk.com) have also demonstrated substantial activity in the metastatic setting [3]. Symptom scales of pain, fatigue, insomnia, and diarrhea favored FAC therapy, while the nausea and vomiting symptom scale favored AP therapy. Five-year survival for female breast cancer shows an unusual pattern with age: survival gradually increases from 85% in women aged 15-39 and peaks at 92% in 60-69 year olds; survival falls … A second phase III trial compared paclitaxel (200 mg/m2) with doxorubicin (75 mg/m2) in 331 patients as first‐line chemotherapy for metastatic disease [39]. Identify trials that have demonstrated a survival benefit with a modern chemotherapeutic agent or regimen in MBC. In the treatment of MBC, there is an underlying assumption that improvements in overall response rates would translate into long‐term survival benefits. I’m a cancer patient and I will have fun, dammit! Depending on the individual patient and specific treatment goals, either can be appropriate. Both regimens were associated with a high rate of grade 3–4 hematologic toxicities, though neutropenia and febrile neutropenia occurred more frequently with TAC. Nonetheless, it is estimated that 40,410 women in the U.S. will die of breast cancer in 2005, with breast cancer ranking second only to lung cancer in cancer‐related mortality in women. Physician experiences and preferences in the treatment of HR+/HER2− metastatic breast cancer in the United States: a physician survey. The overall response rate with docetaxel was significantly higher than the rate with doxorubicin, though there were no differences in median time to disease progression or overall survival time (Table 4). A phase II study of gemcitabine plus paclitaxel in patients with metastatic breast cancer and prior anthracycline treatment. Ok, this sounds ridiculous doesn’t it? Mature results of a large multicenter phase II trail, Phase II study of capecitabine (Xeloda®) in patients with advanced breast cancer (ABC), previously treated with anthracyclines and taxanes, Combination versus sequential single‐agent therapy in metastatic breast cancer, Phase III trial of doxorubicin, paclitaxel, and the combination of doxorubicin and paclitaxel as front‐line chemotherapy for metastatic breast cancer: an intergroup trial (E1193), A randomized phase II study of combination, alternating and sequential regimens of doxorubicin and docetaxel as first‐line chemotherapy for women with metastatic breast cancer, Concomitant versus sequential administration of epirubicin and paclitaxel as first‐line therapy in meta‐static breast carcinoma: results for the Gruppo Oncologico Nord Ovest randomized trial, Multicenter randomized trial comparing sequential with concomitant administration of doxorubicin and docetaxel as first‐line treatment of metastatic breast cancer: a Spanish Breast Cancer Research Group (GEICAM‐9903) phase III study, Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2, Randomized phase II trial of the efficacy and safety of trastuzumab combined with docetaxel in patients with human epidermal growth factor receptor 2‐positive meta‐static breast cancer administered as first‐line treatment: the M77001 study group, E2100: a randomized phase III trial of paclitaxel versus paclitaxel plus bevacizumab as first‐line therapy for locally recurrent or metastatic breast cancer, Presented at the 41st Annual Meeting of the American Society of Clinical Oncology, Long‐term follow‐up of patients with complete remission following combination chemotherapy for metastatic breast cancer, Cytotoxic and hormonal treatment for metastatic breast cancer: a systematic review of published randomized trials involving 31,510 women, Response to chemotherapy is a major parameter influencing long‐term survival of metastatic breast cancer patients, Objective response to chemotherapy as a potential surrogate end point of survival in metastatic breast cancer patients, The impact of new chemotherapeutic and hormonal agents on the survival of women with metastatic breast cancer in a population based cohort, Prospective randomized trial of docetaxel versus mitomycin plus vinblastine in patients with meta‐static breast cancer progressing despite previous anthracycline‐containing chemotherapy. I found that journaling helped me cope with the pain and fear I was experiencing. Enter your email address below and we will send you your username, If the address matches an existing account you will receive an email with instructions to retrieve your username. Gastrointestinal adverse events and hand‐foot syndrome were more common with combination therapy, whereas febrile neutropenia, sepsis, arthralgia, and myalgia were more common with single‐agent docetaxel. The findings suggest that chemotherapy may be considered for the remaining 30% of women with HR-positive, HER2-negative, node-negative breast cancer – those who are: any age … Two important phase III trials have evaluated the addition of trastuzumab to chemotherapy in women with HER‐2–overexpressing MBC [14, 15]. Paclitaxel was also directly compared with albumin‐bound paclitaxel (ABI‐007) in 460 patients with MBC (who had not received prior paclitaxel or docetaxel for MBC) in a randomized phase III trial [35]. Survival Impact of Integrative Cancer Care in Advanced Metastatic Breast Cancer. A randomized phase II study compared AD (50/75 mg/m2) with FAC (500/50/500 mg/m2) as first‐line chemotherapy in 215 MBC patients [28]. With chemotherapy regimens, the taxanes have figured prominently in those trials exhibiting a survival benefit. In two similar comparisons of epirubicin and paclitaxel versus epirubicin and cyclophosphamide in women with MBC, there were also no differences in either overall response rates or survival times [43, 44]. Tapping into an ancient evolutionary survival mechanism, cancer cells enter into a sluggish, slow-dividing state to survive the harsh environment created by chemotherapy or other targeted … Breast cancer survivor shares her chemotherapy tips for patients who need chemotherapy. Among those who did not have chemotherapy, the five-year survival rate without distant metastasis was 94 percent. The taxanes docetaxel and paclitaxel are highly active in MBC and have established activity in patients who have been previously treated with anthracyclines, including patients with anthracycline‐refractory disease [31, 32]. The combination of chemotherapy and trastuzumab resulted in significantly higher overall response rates with a longer median time to disease progression and overall survival time than with chemotherapy alone (Table 6). Combination therapies generally result in higher overall response rates and times to disease progression than with sequential single agents, but usually at a cost of greater toxicity. With the potential to realize clinical synergism between chemotherapy and the biologics, significant improvements in overall survival with the use of these agents in combination have been seen [14–16]. The second study compared single‐agent docetaxel (100mg/m2) with single‐agent paclitaxel (175mg/m2) in 449 patients with MBC who had previously received first‐line metastatic therapy with an anthracycline‐based regimen or had disease progression within 12 months of completing anthracycline‐based adjuvant or neoadjuvant therapy [23]. We analyze the effect of time between the end of NACT and surgery on overall survival (OS) and disease-free survival (DFS) in breast cancer … Of note, patients who received docetaxel first, followed by trastuzumab at progression, had worse survival than those who received the combination initially. Use the link below to share a full-text version of this article with your friends and colleagues. Asia-Pacific Journal of Clinical Oncology. Learn about our remote access options, Baylor‐Sammons Cancer Center, Dallas, Texas, USA. Two additional phase III trials compared single‐agent docetaxel with either sequential methotrexate and 5‐fluorouracil or 5‐fluorouracil in combination with vinorelbine (Table 2) [33, 34]. It … Prior adjuvant chemotherapy was allowed, and patients could have received prior doxorubicin up to a cumulative dose of 240 mg/m2. Demonstrating this point are the results of Intergroup trial E1193, in which patients were randomized to receive either paclitaxel (Taxol®; Bristol‐Myers Squibb, Princeton, NJ, http://www.bms.com), docetaxel (Taxotere®; Aventis Pharmaceuticals Inc., Bridgewater, NJ, http://www.aventispharma‐us.com), or a combination of the two as first‐line treatment of MBC [10]. Grade 3–4 toxicities, including fatigue, alopecia, and infection, were more frequent with docetaxel. The debate concerning combination therapy versus sequential single agents continues. In comparison with the combination of 5‐fluorouracil and vinorelbine, no significant differences in response or survival outcomes were seen between study arms, though overall tolerability was greater with docetaxel. Other groups have compared combination chemotherapy with sequential therapy in randomized trials (Table 1), showing similar outcomes in terms of response rate and progression‐free and overall survival [11–13]. In contrast to the previous trial, significant differences in time to disease progression and overall survival time along with a superior overall response rate were seen with AD versus FAC. In addition, the development of targeted biologic agents active against MBC, such as trastuzumab and bevacizumab, has demonstrated great potential for enhancing the effects of chemotherapy and producing meaningful survival improvements. As newer types of cancer treatment are developed, such as immunotherapy, doctors may find that these treatments also cause late effects in cancer survivors. There are things you can do to minimize the side-effects and to make yourself more comfortable. That trial compared doxorubicin and paclitaxel (50/220 mg/m2) with FAC (500/50/500 mg/m2) as first‐line chemotherapy in 267 anthracycline‐naïve MBC patients [29]. Neutropenia, febrile neutropenia, and infections occurred more frequently with doxorubicin. Synergistic activity has been observed in cellular models between trastuzumab and several chemotherapeutic agents, including docetaxel and carboplatin (Paraplatin®; Bristol‐Myers Squibb), while additive activity has been observed with paclitaxel, doxorubicin, and epirubicin [45]. Have fun. Breast Cancer Survival Rates The overall 5-year relative survival rate for breast cancer is 90%. In a separate study, a QoL analysis was performed in a sample of 400 patients who received either chemotherapy with trastuzumab (n = 208) or chemotherapy alone as first‐line therapy for MBC [46]. Patients could not have received any prior anthracycline therapy, though prior alkylating agent–based chemotherapy in the adjuvant setting was permitted. The overall five-year survival rate for breast cancer is 90%. Last summer, I also had five close friends get married. Approximately two thirds of the patients in the chemotherapy‐alone arm crossed over to receive trastuzumab at disease progression. 304 Study Group, Randomized phase III study of docetaxel compared with paclitaxel in metastatic breast cancer, Superior survival with capecitabine plus docetaxel combination therapy in anthracycline‐pre‐treated patients with advanced breast cancer: phase III trial results, Global phase III study of gemcitabine plus paclitaxel (T) as frontline therapy for metastatic breast cancer (MBC): first report of overall survival, Gemcitabine plus paclitaxel (GT) versus paclitaxel (T) as first‐line treatment for anthracycline pre‐treated metastatic breast cancer (MBC): interim results of a global phase III study, Initial paclitaxel improves outcome compared with CMFP combination chemotherapy as front‐line therapy in untreated metastatic breast cancer, Phase II study comparing AT to FAC as first line chemotherapy in patients with MBC, Doxorubicin and paclitaxel versus fluorouracil, doxorubicin, and cyclophosphamide as first‐line therapy for women with metastatic breast cancer: final results of a randomized phase III multicenter trial, First‐line gemcitabine versus epirubicin in postmenopausal women aged 60 or older with metastatic breast cancer: a multicenter, randomized, phase III study, Docetaxel: an update of its use in advanced breast cancer, Docetaxel compared with sequential methotrexate and 5‐fluorouracil in patients with advanced breast cancer after anthracycline failure: a randomised phase III study with crossover on progression by the Scandinavian Breast Group, Docetaxel vs 5‐fluorouracil plus vinorelbine in metastatic breast cancer after anthracycline therapy failure, Superior efficacy of albumin‐bound paclitaxel, ABI‐007, compared with polyethylated castor oil‐based paclitaxel in women with metastatic breast cancer: results of a phase III trial, Survival benefit with capecitabine/docetaxel versus docetaxel alone: analysis of therapy in a randomized phase III trial, Gemcitabine plus paclitaxel (GT) versus paclitaxel (T) as first‐line treatment for anthracycline pre‐treated metastatic breast cancer (MBC): quality of life (QoL) and pain palliation results from the global phase III study, Prospective randomized trial of docetaxel versus doxorubicin in patients with metastatic breast cancer, Paclitaxel versus doxorubicin as first‐line single‐agent chemotherapy for metastatic breast cancer: a European Organization for Research and Treatment of Cancer randomized study with cross‐over, Docetaxel and doxorubicin compared with doxorubicin and cyclophosphamide as first‐line chemotherapy for metastatic breast cancer: results of a randomized, multicenter phase III trial, Final results of the phase III randomized trial comparing docetaxel (T) doxorubicin (A) and cyclophosphamide (C) to FAC as first line chemotherapy (CT) for patients (pts) with metastatic breast cancer (MBC), Doxorubicin and paclitaxel versus doxorubicin and cyclophosphamide as first‐line chemotherapy in metastatic breast cancer: the European Organization for Research and Treatment of Cancer 10961 multicenter phase III trial, UKCCCR trial of epirubicin and cyclophosphamide (EC) versus epirubicin and Taxol (ET) in the first‐line treatment of women with metastatic breast cancer (MBC), Multicentric phase III study in first line treatment of advanced metastatic breast cancer (ABC). Optimization of chemotherapy for the treatment of MBC remains an ongoing effort. and you may need to create a new Wiley Online Library account. Four large, multicenter trials have evaluated single‐agent capecitabine in patients with MBC that has progressed during or following anthracycline and taxane therapy [4–8], showing consistent efficacy and safety data. Add in what may lie ahead—surgery, radiation, chemotherapy—and the fear can be amplified. In addition to the E1193 trial, two randomized phase III trials have evaluated a single‐agent taxane therapy versus single‐agent doxorubicin for patients with MBC without prior anthracycline exposure [38, 39]. Both the overall response rate and median time to disease progression were nearly doubled by the addition of trastuzumab. Overall, toxicities were consistent with those expected, with the combination producing more grade 3–4 neutropenia than single‐agent docetaxel. The absolute median survival difference was 6.5 months, representing a 40% longer survival time than in the FAC arm. Overall, there is a growing body of phase III data on MBC that demonstrates that the introduction of modern chemotherapeutic agents, such as the taxanes, antimetabolites, and targeted biologic agents, has helped to improve survival outcomes in MBC. Phase II data indicate a modest response rate of 9% for bevacizumab alone in previously treated MBC patients [49]. Breast Cancer. The monoclonal antibody trastuzumab targets an extracellular domain of the HER‐2 receptor [45]. The use of combination therapy versus monotherapy or sequential single agents remains a controversial issue [9]. The mortality rate from breast cancer declined approximately 2.3% per year from 1990 through 2001, due in large part to increased awareness, earlier detection, and improved therapies [1]. Early data from the combination of paclitaxel and bevacizumab also appear to support a survival benefit. Overall response rates and times to disease progression were not different between the two study arms (Table 4). The incidences of grade 3–4 neutropenia were similar for both arms, although febrile neutropenia occurred more frequently with AD. Anthracycline … Bevacizumab is a monoclonal antibody targeting vascular endothelial growth factor (VEGF). Targeted biologic therapies offer an entirely new treatment dimension for patients with MBC. Paclitaxel and docetaxel were administered to 10% and 14% of patients, respectively, in the FAC group and each was administered to 1% of patients in the AP group. Surviving Metastatic Breast Cancer for 18 Years: A Case Report and Review of the Literature. Upregulation of S100A10 in metastasized breast cancer stem cells. And, do you know what, I had a blast! In a phase III trial comparing AP (60/175 mg/m2) with AC (60/600 mg/m2) as first‐line chemotherapy in 265 anthracycline‐naïve patients, no differences in response or survival outcomes were seen between treatment arms [42]. The second phase III trial compared the combination of paclitaxel (175 mg/m2) and gemcitabine (1,250 mg/m2) with single‐agent paclitaxel (175 mg/m2) in 529 patients with MBC who had previously received an anthracycline but had no prior chemotherapy for metastatic disease [25, 26]. In the first of these studies, 392 patients with progressive MBC following anthracycline‐based chemotherapy were randomized to receive either single‐agent docetaxel (100 mg/m2) or combination therapy with mitomycin (Mutamycin®; Bristol‐Myers Squibb) (12 mg/m2) and vinblastine (Velban®; Eli Lilly and Company) (6 mg/m2) [22]. I think this was wedding number one. The overall response rate, median time to disease progression, and median overall survival time were all statistically superior with the combination, with an absolute improvement in median overall survival time of 3 months. Relative survival rates. Among the three trials evaluating paclitaxel‐based combinations, one demonstrated significantly better outcomes favoring the taxane combination. A QoL analysis found no difference between treatment groups, and overall QoL was maintained. Clinical Implications of the Progression‐Free Survival Endpoint for Treatment of Hormone Receptor‐Positive Advanced Breast Cancer. Abbreviation: CMFP, cyclophosphamide, methotrexate, fluorouracil, and prednisone. The median time to disease progression and median overall survival time were statistically significantly longer in the docetaxel arm (Table 2). Myelo‐suppression was particularly rare, as was alopecia. The most important adverse event was a higher incidence of congestive heart failure in patients receiving trastuzumab with AC. While grade 3–4 neutropenia occurred more frequently with docetaxel, other acute adverse events were similar in the two treatment arms. Combinations of traditional chemotherapeutics with targeted biologic agents, such as trastuzumab (Herceptin®; Genentech, Inc., South San Francisco, CA, http://www.gene.com) and more recently bevacizumab (Avastin®; Genentech, Inc.), appear to present a new dimension. Surgery, in addition to treatments like chemotherapy and radiation therapy, may increase the length of survival for metastatic breast cancer patients, according to a new study. With trastuzumab therapy, there has even been an indication of an improvement in overall QoL following treatment. It made such an impact on my life. The overall response rate, median time to disease progression, and overall survival time were significantly better with AP than with FAC, with AP producing a median survival time that was 4 months longer. If progression or disease recurrence takes place in a relatively short time (i.e., <12 months), the use of different classes of classes of agents is generally preferable. With respect to QoL measures, in general, treatment regimens for MBC do not appear to impair overall QoL. Contact your local chapter of the American Cancer Society for more information. The absolute difference in median survival time in this study was impressive, at 8.5 months, 37% higher than with docetaxel alone. There are a number of agents with established single‐agent activity, with the anthracyclines and taxanes generally considered the most active. Building on this, a phase III trial comparing the combination of bevacizumab and capecitabine with capecitabine alone was conducted, enrolling MBC patients who had previously received both an anthracycline and a taxane (Table 6) [50]. After completing this course, the reader will be able to: Cancer Diagnostics and Molecular Pathology, Health Outcomes and Economics of Cancer Care, New Drug Development and Clinical Pharmacology, Precision Medicine Clinic: Molecular Tumor Board, I have read and accept the Wiley Online Library Terms and Conditions of Use, Epidemiology, and End Results (SEER) Program, Optimizing the treatment of metastatic breast cancer, Multicenter phase II study of capecitabine in paclitaxel‐refractory metastatic breast cancer, Capecitabine (Xeloda) in 162 patients with paclitaxel‐pretreated MBC: updated results and analysis of dose modification, Multicenter, phase II study of capecitabine in taxane‐pretreated metastatic breast carcinoma patients, Capecitabine: the new standard in metastatic breast cancer failing anthracycline and taxane containing chemotherapy?
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