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]. 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. Approximately the same number of patients on the FAC and AP arms received second‐line chemotherapy (44% and 48%, respectively). Abbreviations: AC, doxorubicin and cyclophosphamide; AD, doxorubicin and docetaxel; AP, paclitaxel and doxorubicin; DAC, docetaxel, doxorubicin, cyclophosphamide; EC, epirubicin and cyclophosphamide; EP, epirubicin and paclitaxel; FAC, 5‐fluorouracil, doxorubicin, and cyclophosphamide; NR, not reported. A study of the AGO Breast Cancer Group, Rational combinations of trastuzumab with chemotherapeutic drugs used in the treatment of breast cancer, Effects on quality of life of combined trastuzumab and chemotherapy in women with metastatic breast cancer, Antiangiogenic therapy of cancer: current and emerging concepts, Inhibition of vascular endothelial growth factor‐induced angiogenesis suppresses tumour growth in vivo, A phase II dose‐escalation trial of bevacizumab in previously treated metastatic breast cancer, Randomized phase III trial of capecitabine compared with bevacizumab plus capecitabine in patients with previously treated metastatic breast cancer patients. Prevalence and characteristics of patients with metastatic cancer who receive no anticancer therapy. Global QoL measures were similar for both treatment arms. Tumor angiogenesis and novel antiangiogenic strategies. It … Capecitabine and gemcitabine, two antimetabolite cytotoxic agents, have shown high activity and acceptable tolerability in a range of settings for MBC. A common feature in many of these trials has been the use of a taxane, and more recently, a taxane combined with an antimetabolite. While grade 3–4 neutropenia occurred more frequently with docetaxel, other acute adverse events were similar in the two treatment arms. Despite advances in the treatment of breast cancer, approximately 30% of women initially diagnosed with earlier stages of breast cancer eventually develop recurrent advanced or metastatic disease. We report the data for the secondary end point of disease-free survival … 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]. A QoL analysis was conducted, and though interpretation of the results was limited, there were no apparent differences in QoL between treatment groups. 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. One important caveat, however, is the potential for congestive heart failure. 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]. With respect to QoL measures, in general, treatment regimens for MBC do not appear to impair overall QoL. Number of times cited according to CrossRef: Productivity costs associated with metastatic breast cancer in younger, midlife, and older women. 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). 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]. Weighted gene correlation network analysis identifies RSAD2, HERC5, and CCL8 as prognostic candidates for breast cancer. In the treatment of MBC, there is an underlying assumption that improvements in overall response rates would translate into long‐term survival benefits. 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]. Finding out I needed to have chemotherapy felt almost as upsetting and frightening as finding out I had cancer. The overall response rate and median time to disease progression were statistically superior with AD than with AC, though the median overall survival time did not differ between the two treatment arms (Table 5). And, do you know what, I had a blast! 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]. For patients treated with docetaxel alone, crossover to single‐agent capecitabine was not mandatory. Anthracycline … Grade 3–4 neutropenia occurred more frequently with AP, although the incidence of febrile neutropenia was low in both arms. The role of the taxanes, antimetabolites, and biologics in extending survival in MBC is discussed. Ok, this sounds ridiculous doesn’t it? After completion of therapy, fatigue scores were significantly better than baseline scores in patients receiving chemotherapy and trastuzumab (p < .05). Measures of Outcome in Metastatic Breast Cancer: Insights From a Real‐World Scenario. 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. Background: A randomized phase 2 trial in women with HER2-negative breast cancer has shown that adding zoledronic acid (ZOL) to neoadjuvant chemotherapy (CT) has potential anticancer benefits in postmenopausal and triple-negative (TN) breast cancer patients. 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]. Treatment Advances in Solid Tumors During the Past Decade: Benchmark Studies Impacting Survival and Quality of Life. At the time of disease progression, patients were to be crossed over to the alternate treatment. Stage I and II breast cancers. I bought five fun wigs (pink, purple, white, blonde, brown – all varying lengths and styles). Clinically, trastuzumab therapy is generally well tolerated. There was no planned crossover design, and further treatment at the time of disease progression was at the investigator's discretion. 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). Journal of Cellular and Molecular Medicine. If time to recurrence is several years following adjuvant therapy, retreatment with prior active agents may be desirable. Breast cancer survival data in this table are from people diagnosed on or after January 1, 2018 who did not get neoadjuvant therapy. In both the single‐agent arms, patients were crossed over to treatment with the alternate single agent at the time of disease progression. 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. A survival advantage with the use of single‐agent docetaxel in women with anthracycline‐pretreated MBC has been observed in two of four randomized phase III trials (Table 2) [22, 23, 33, 34]. The combination of doxorubicin (50 mg/m2) and docetaxel (75 mg/m2) (AD) was compared with doxorubicin (60 mg/m2) and cyclophosphamide (500 mg/m2) (AC) as first‐line chemotherapy in 429 women with MBC [40]. Toxicity was in general less with sequential administration. 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]. The average rate for women surviving at least 15 years after being diagnosed with breast cancer is 80 percent. Seven phase III trials have evaluated a taxane in combination with an anthracycline versus a standard anthracycline‐based combination in patients with MBC (Table 5) [28, 29, 40–44]. You will make it through. 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. 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. 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. 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 … 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]. Of note, patients who received docetaxel first, followed by trastuzumab at progression, had worse survival than those who received the combination initially. Breast cancer survivor shares her chemotherapy tips for patients who need chemotherapy. The median overall survival time with docetaxel was 11.4 months, 2.7 months longer than with mitomycin and vinblastine. 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]. The median time to disease progression and median overall survival time were statistically significantly longer in the docetaxel arm (Table 2). Response rates of 15%–26% were demonstrated, with a median survival time of approximately 1 year. Leukopenia, thrombocytopenia, nausea and vomiting, and mucositis occurred more frequently with CMFP. Phase II data indicate a modest response rate of 9% for bevacizumab alone in previously treated MBC patients [49]. 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). Though numerous randomized clinical trials have shown improvements in overall response rates, few have found clear survival benefits. In addition, the higher overall response rates with combination therapy versus sequential single agents may not necessarily translate into superior survival outcomes. I was bald, I was tired, I felt like I could die … but I could not miss the wedding of my brother and my four other close friends. It is interesting to note that, among all these trials, in no case has a docetaxel‐based regimen been inferior with respect to overall survival outcome. 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). Approximately two thirds of the patients in the chemotherapy‐alone arm crossed over to receive trastuzumab at disease progression. 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. 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. Dr. O'Shaughnessy has acted as a consultant for Eli Lilly, Pfizer, Roche, sanofi‐aventis, Abraxis, and Genentech and has received support from Roche, sanofi‐aventis, Lilly, Genentech, and Abraxis. Of the 60% of patients who received additional chemotherapy, 29% in the AC group received docetaxel as additional treatment versus 6% in the AD group. 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]. Docetaxel was associated with more toxicities than paclitaxel, including grade 3–4 neutropenia, asthenia, edema, infection, and stomatitis. As an initial presentation, metastatic breast cancer (MBC) is uncommon, occurring in only about 6% of newly diagnosed cases [2]. Metastatic breast cancer (MBC) remains essentially incurable, and goals of therapy include the palliation of symptoms, delay of disease progression, and prolongation of overall survival time without negatively impacting quality of life. Combination therapy resulted in a significantly higher overall response rate and longer progression‐free and overall survival times than single‐agent paclitaxel (Table 3). Significantly greater overall response rate and median time to disease progression were seen with the combination (Table 6). There is no defined consensus on the optimal time between NACT and surgery. The results of a phase III trial evaluating single‐agent docetaxel (100 mg/m2) with or without trastuzumab as first‐line therapy for MBC have also shown a significant benefit from the addition of trastuzumab (Table 6) [15]. Overall, toxicities were consistent with those expected, with the combination producing more grade 3–4 neutropenia than single‐agent docetaxel. QoL scores were similar in the two treatment arms, and overall global health quality was generally maintained over time. Identify trials that have demonstrated a survival benefit with a modern chemotherapeutic agent or regimen in MBC. Prior adjuvant chemotherapy was permitted. The song says \"It ain't over 'til it's over,\" but when you've had breast cancer, you discover that it's not even over when it's over. I forgot about being a cancer patient and all the guests assumed I was the “fun” chick in the wigs. Nonetheless, there is an increasing number of randomized clinical trials that have documented significant survival differences. Don't deal with loneliness on your own. 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]. Bevacizumab decreases interstitial fluid pressure in tumors, improving drug delivery and penetration [47]. 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]. 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]. Find an outlet. Early-stage localized breast cancer ; Tumor is less than 2 cm (0.8 inches) in size and is node negative; Stage II tumors have spread to the axillary lymph nodes … Optimization of chemotherapy for the treatment of MBC remains an ongoing effort. I downed a few ginger ales, grabbed my dancing shoes and went to every single wedding. Breast Cancer. 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. … 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. In a multivariate model that factored in significant prognostic factors, however, this difference was found to be significant (p = .025). A prognostic 10‐lncRNA expression signature for predicting the risk of tumour recurrence in breast cancer patients. Clinical outcomes with taxane combination regimens in anthracycline‐pretreated breast cancer patients have been very encouraging, with significant survival benefits observed in two phase III trials [24–26]. Abbreviation: CMFP, cyclophosphamide, methotrexate, fluorouracil, and prednisone. Among the three trials evaluating paclitaxel‐based combinations, one demonstrated significantly better outcomes favoring the taxane combination. These include specific tumor biology, growth rate of disease, presence of visceral metastases, history of prior therapy and response, risk for toxicity, and patient preference. Preliminary results from a phase III trial of paclitaxel with or without bevacizumab as first‐line treatment of 715 patients with MBC appear very promising [16]. While it is generally accepted that chemotherapy can provide substantial clinical benefit, the potential to positively impact overall survival and QoL remains the subject of debate. Kim Tronic knows this all too well.At 36, she was diagnosed with stage 3 ovarian cancer and her care team recommended a treatment plan that included 18 weeks of chemo. Use the link below to share a full-text version of this article with your friends and colleagues. Several studies have shown an association between pCR to neoadjuvant chemotherapy for breast cancer and better disease-free survival, as well as better overall survival. Overall response rates and times to disease progression were not different between the two study arms (Table 4). 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]. Grade 3–4 neutropenia occurred frequently in both treatment arms, and febrile neutropenia and infection occurred more commonly with the AD combination. In addition, patients who received trastuzumab had a significant improvement in global QoL scores (p < .05). First of all, chemo is a drag. Fluid Shear Stress Induces Drug Resistance to Doxorubicin and Paclitaxel in the Breast Cancer Cell Line MCF7. 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