A META-ANALYSIS STUDY OF POLYCHEMOTHERAPY VERSUS MONOCHEMOTHERAPY IN PATIENTS OF METASTATIC BREAST CANCER
Abstract
Polychemotherapy and intermittent monochemotherapy regimens in metastatic breast cancer were examined in a meta analysis that included both tumor response rate and toxicities. Randomized controlled studies (conducted during 1990-2008) comparing monochemotherapy and poly-chemotherapy in advanced breast cancer patients were selected from electronic databases. Meta-analysis for response rate and toxicities [nausea and vomiting, toxic death, alopecia and reduced white cell count (WCC)] was performed using the Mantel-Haenszel method. The heterogeneity among the trials was assessed through a χ2 statistic, I2 and visual inspection of the forest plots. Analysis of eligible studies reveals statistical significant difference in response rate (OR 0.72, 95% CI 0.65-0.79), nausea and vomiting (OR 0.80, 95% CI 0.67-0.59), Alopecia (OR 0.75, 95% CI 0.64-0.88) and reduced WCC (OR 0.55, 95% CI 0.48-0.62) which favours polychemotherapy except toxic death (OR 0.87, 95% CI 0.58-1.29). There was marked evidence of heterogeneity in all end points except toxic death. This meta analysis shows the superiority of efficacy but not of safety of polychemotherapy over that of a single agent. However, the choice of treatment should be based on the response to the therapy, toxicity, patient preference, presence of metastases or imminent complications requiring aggressive and rapid tumor control.
Keywords:
Meta Analysis, Monochemotherapy, Polychemotherapy, Nausea, Reduced WCC, Response rate, Toxic death, VomitingDOI
https://doi.org/10.25004/IJPSDR.2016.080302References
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3. Hortobagyi GN, Piccart-Gebhart MJ. Current Management of Advanced Breast Cancer. Seminars in Oncology 1996; 23(11):1-5.
4. Hortbagyi GN. ASCO Conference. 2003. Breast cancer is the most common type of cancer in women, and the most common cause of cancer-death for women. In 2005, an estimated 500,000 women died of this disease worldwide (WHO 2006).
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8. Bruzzi P, Mastro LD, Sormani MP, Bastholt L, Denova M, Focan C, et. al. Objective response to chemotherapy as a potential surrogate end point of survival in metastatic breast cancer patients. J Clin Oncol 2005; 23:5117–25.
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12. Australia and New Zealand Breast Cancer Trials Group. Phase III randomised trial to evaluate single agent (MTZ) versus combination (CMFp) cytotoxic therapy in advanced breast cancer. Annual Scientific Report 2001.
13. Berruti D. Time to progression in metastatic breast cancer patients treated with epirubicin is not im-proved by the addition of either cisplatin or lonidamine: final results of a phase III study with a factorial design. Journal of Clinical Oncology 2002; 20(20):4150-59.
14. Bishop J. Initial paclitaxel improves outcome compared with CMFP combination chemotherapy as front-line therapy in untreated metastatic breast cancer. Journal of Clinical Oncology 1999; 17(8):2355-64.
15. Bonneterre J. Docetaxel vs 5-fluorouracil plus vinorelbine in metastatic breast cancer after anthra-cycline therapy failure. British Journal of Cancer 2002; 87(11):1210-15.
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17. Erkisi M, Bilkay BC, Seyrek E, Hazar B, Burgut R. Refractory breast cancer: a comparison of two different chemotherapy regimens. Journal Chemotherapy 1997; 9:442-5.
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26. Nielsen D, Dombernowsky P, Skovsgaard T, Jensen J, Andersen E, Engelholm SA, et. al. Epirubicin or epirubicin and vindesine in advanced breast cancer. A phase III study. Annals of Oncology 1990; 1(4):275-80.
27. Nielsen D, Dombernowsky P, Larsen SK, Hansen OP, Skovsgaard T. Epirubicin or epirubicin and cisplatin as first line therapy in advanced breast cancer. A phase III. Cancer Chemotherapy & Pharmacology 2000; 46(6):459-66.
28. Norris B, Pritchard KI, Myles JJ, Bennett K, Marlin S, Skillings J, et. al. Phase III comparative study of vinorelbine combined with doxorubicin versus doxorubicin alone in disseminated metastic/recurrent breast cancer: National cancer institute of Canada Clinical Trials Group Study MA8. Journal of Clinical Oncology 2000; 18:2385-94.
29. O'Shaughnessy JA, Blum J, Moiseyenko V, Jones SE, Miles D, Bell D, et. al. Randomised, open-label, phase II trial of oral capecitabine vs. a reference arm of intravenous CMF (cyclophosphamide, methotrexate and 5-fluorouracil) as first-line therapy for advanced breast cancer. Annals of Oncology 2001; 12:1247-54.
30. O'Shaughnessy J, Miles D, Vukelja S, Moiseyenko V, Ayoub JP, Cervantes G, et. al. Superior survival with capecitabine plus docetaxel combination therapy in anthracycline-pretreated patients with advanced breast cancer: phase III trial results. Journal of Clinical Oncology 2002; 20(12):2812-23.
31. Sjostrom J, Blomqvist C, Mouridsen H, Pluzanska A, Ottosson-Lonn S, Bengtsson NO. Docetaxel compared with sequential methotrexate and 5-fluorouracil in patients with advanced. European Journal of Cancer 1999; 35(8):1194-1201.
32. Sledge GW, Neuberg D, Bernardo P, Ingle J, Martino S, Rowinsky EK, et. al. Phase III trials of Doxorubicin, Paclitaxel, and the Combination of Doxorubicin and Paclitaxel as Front Line Chemotherapy for Metastatic Breast Cancer: An Intergroup Trial (EII93). Journal of Clinical Oncology 2003; 21(4):588-92.
33. Stockler MR, Sourjina T, Harvey V, Francis P, Byrne M, Hazel VG, et. al. A randomized trial of capecitabine given intermittently versus continuously versus classical CMF as first line chemotherapy for women with advanced breast can-cer unsuited to more intensive treatment. Proceedings of the American Society of Clinical Oncolcogy. 2006; Vol. Abstract 6066.
34. Takayama T, Nomura Y. A double-blind randomized comparative study of oral 5-fluorouracil (5-FU), cyclophosphamide. Japanese Journal of Cancer & Chemotherapy 2000; 27(1):73-80.
35. Tashiro H, Nomura Y, Ohsaki A. A double blind comparative study of (FT) and UFT. Japanese Journal of Clinical Oncology 1994; 24(4):212-17.
36. Thomas ES, Gomez HL, Li RK, Chung HC, Fein LE, Chan VF, et. al. Ixabepilone Plus Capecitabine for Metastatic Breast Cancer Progressing After Anthracycline and Taxane Treatment Ixabepilone Plus Capecitabine for Metastatic Breast Cancer Progressing After Anthracycline and Taxane Treatment. Journal of Clinical Oncology 2008; 25(33):5210-17.
37. Venturino A, Comandini D, Simoni C, Merlini L, Naso C, Palumbo R, et. al. Is salvage chemotherapy for metastatic breast cancer always effective and well tolerated? Breast Cancer Research & Treatment 2000; 60(3):195-200.
38. Early Breast Cancer Trialists' Collaborative Group: Systemic treatment of early breast cancer by hormonal, cytotoxic, or immune therapy. Lancet 1992; 339:1-15.
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41. Hortobagyi GN. Treatment of breast cancer. N Engl J Med 1998; 339:974–984.
42. Canellos GP, Pocock SJ, Taylor SG. Combination chemotherapy for metastatic breast carcinoma. Prospective comparison of multiple drug therapy with L-phenylalanine mustard. Cancer 1976; 38:1882–1886.
43. Rubens RD, Knight RK, Hayward JL. Chemotherapy of advanced breast cancer: A controlled randomized trial of cyclophosphamide versus a four drug combination. Br J Cancer 1975; 32:730 –736.
44. Carmo-Pereira J, Costa FO, Henriques E. Single drug vs combination cytotoxic chemotherapy in advanced breast cancer: A randomized study. Eur J Cancer 1980; 16:1621–1625.
45. Steiner R, Stewart JF, Cantwell BM. Adriamycin alone or combined with vincristine in the treatment of advanced breast cancer. Eur J Cancer Clin Oncol 1983; 19:1553–1557.
46. Andersson M, Daugaard S, von der Maase H. Doxorubicin versus mitomycin versus doxorubicin plus mitomycin in advanced breast cancer: A randomized study. Cancer Treat Rep 1986; 70:1181–1186.
47. Gundersen S, Kvinnsland S, Klepp O. Weekly Adriamycin versus VAC in advanced breast cancer. A randomized trial. Eur J Cancer Clin Oncol 1986; 22:1431–1434.
48. Ahmann DL, Schaid DJ, Bisel HF. The effect on survival of initial chemotherapy in advanced breast cancer: Polychemotherapy versus single drug. J Clin Oncol 1987; 5:1928 –1932.
49. Vaughn CB, Green SJ, O’Bryan R. VP-16_Adriamycin vs. Adriamycin alone in advanced adenocarcinoma of the breast, phase II, a randomized trial: A Southwest Oncology Group study. Med Pediatr Oncol 1988; 16:312–319.
50. A’Hern RP, Smith IE, Ebbs SR. Chemotherapy and survival in advanced breast cancer: The inclusion of doxorubicin in Cooper type regimens. Br J Cancer 1993; 67:801– 805.
51. Alba E, Martin M, Ramos M. 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. J Clin Oncol 2004; 22:2587–2593.
52. Conte PF, Guarneri V, Bruzzi P. Concomitant versus sequential administration of epirubicin and paclitaxel as first-line therapy in metastatic breast carcinoma: Results for the Gruppo Oncologico Nord Ovest randomized trial. Cancer 2004; 101:704 –712.
53. Koroleva I, Wojtukiewicz M, Za-luski J. Preliminary results of a phase II randomized trial of Taxotere (T) and doxorubicin (A) given in combination or sequentially as first line chemotherapy (CT) for metastatic breast cancer (MBC). Proc Am Soc Clin Oncol 2001; 20:30a.
54. Fountzilas G, Papadimitriou C, Dafni U. Dose-dense sequential chemotherapy with epirubicin and paclitaxel versus the combination, as first line chemotherapy, in ad-vanced breast cancer: A randomized study conducted by the Hel-lenic Cooperative Oncology Group. J Clin Oncol 2001; 19:2232–2239.
55. Cresta S, Grasselli G, Mansutti M. 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. Ann Oncol 2004; 15:433– 439.
2. Devita VT, Young KC, Canellos GP. Combination versus single agent chemotherapy-A review of the basis for selection of drug treatment of cancer. Cancer 1975; 35:98-110.
3. Hortobagyi GN, Piccart-Gebhart MJ. Current Management of Advanced Breast Cancer. Seminars in Oncology 1996; 23(11):1-5.
4. Hortbagyi GN. ASCO Conference. 2003. Breast cancer is the most common type of cancer in women, and the most common cause of cancer-death for women. In 2005, an estimated 500,000 women died of this disease worldwide (WHO 2006).
5. World Health Organisation. Cancer. Fact sheet number 297. http://www.who.int/mediacentre/factsheets/fs297/en/index.html (ac-cessed on April 25 2009).
6. Carter SK. Single and combination non hormonal chemotherapy in breast cancer. Cancer 1972; 30:1543-1555.
7. Hayes DF, Henderson IC, Shapiro CL. Treatment of Metastatic Breast Cancer: Present and Future Prospects. Seminars in Oncology 1995; 22(5):5-21.
8. Bruzzi P, Mastro LD, Sormani MP, Bastholt L, Denova M, Focan C, et. al. Objective response to chemotherapy as a potential surrogate end point of survival in metastatic breast cancer patients. J Clin Oncol 2005; 23:5117–25.
9. Fossati R, Confalonieri C, Torri V. Cytotoxic and hormonal treatment for metastatic breast cancer: a systematic review of published randomized trials involving 31,150 women. J Clin Oncol 1998; 16:3439-3460.
10. Cancer therapy evaluation pro-gram, common terminology criteria for adverse events v3.0 (CTCAE), Publish date: August 9, 2006.
11. Albain KS, Nag S, Calderillo-Ruiz G, Jordaan JP, Llombart A, Pluzanska A, et. al. Global Phase III study of gemcitabine plus paclitaxel versus paclitaxel as frontline therapy for metastatic breast cancer. Proceedings of the American Society of Clinical Oncolcogy. 2004: Abstract 510.
12. Australia and New Zealand Breast Cancer Trials Group. Phase III randomised trial to evaluate single agent (MTZ) versus combination (CMFp) cytotoxic therapy in advanced breast cancer. Annual Scientific Report 2001.
13. Berruti D. Time to progression in metastatic breast cancer patients treated with epirubicin is not im-proved by the addition of either cisplatin or lonidamine: final results of a phase III study with a factorial design. Journal of Clinical Oncology 2002; 20(20):4150-59.
14. Bishop J. Initial paclitaxel improves outcome compared with CMFP combination chemotherapy as front-line therapy in untreated metastatic breast cancer. Journal of Clinical Oncology 1999; 17(8):2355-64.
15. Bonneterre J. Docetaxel vs 5-fluorouracil plus vinorelbine in metastatic breast cancer after anthra-cycline therapy failure. British Journal of Cancer 2002; 87(11):1210-15.
16. Ejlertsen B, Mouridsen HT, Langkjer ST, Andersen J, Sjostrom J, Kjaer M. Phase III study of intravenous vinorelbine in combination with epirubicin versus epirubicin alone in patients with advanced breast cancer: A Scandina-vian Breast Group Trial (SBG9403). Journal of Clincal On-cology 2004; 27:2313-20.
17. Erkisi M, Bilkay BC, Seyrek E, Hazar B, Burgut R. Refractory breast cancer: a comparison of two different chemotherapy regimens. Journal Chemotherapy 1997; 9:442-5.
18. Falkson G. Survival of premeno-pausal women with metastatic breast cancer. Long term follow-up of Eastern Cooperative Group and Cancer and Leukemia Group B studies. Cancer 1990; 66(7):1621-9.
19. Fraser SC. Dobbs HJ, Ebbs SR, Fallowfield LJ, Bates T, Baum M. Combination or mild single agent chemotherapy for advanced breast cancer? CMF vs. British Journal of Cancer 1993; 67(2):402-6.
20. French Epirubicin Study Group. A prospective randomized trial comparing epirubicin monochemotherapy to two fluorouracil, cyclophosphamide, and epirubicin regimens differing in epirubicin dose in advanced breast cancer patients. The French Epirubicin Study Group. Journal of Clinical Oncology 1991; 9(2):305-12.
21. Martín M, Ruiz A, Muñoz M, Balil A, García MJ, Calvo L, et. al. Gemcitabine plus vinorelbine versus vinorelbine monotherapy in patients with metastatic breast cancer previously treated with anthracyclines and taxanes: final results of the phase III Spanish Breast Cancer Research Group (GEICAM) trial. The Lancet 2007; 8:219-225.
22. Heidemann ES. Is first line single agent mitoxantrone in the treatment of high risk metastatic breast cancer patients as effective as combination chemotherapy? No difference in survival but higher quality of life was found in a multicenter randomized trial. Annals of Oncology 2002; 13(11):1717-29.
23. Icli F, Akbulut H, Uner A, Baltali E, Altinbas M, Coskun S. Paclitaxel (T) vs cisplatin + VP-16 (EP) in metastatic breast cancer patients treated with anthracyclines Cisplatin plus oral etoposide (EOP) combination is more effective than paclitaxel in patients with advacned breast cancer pretreated with anthracycline. British Journal of Cancer 2005; 92:639.
24. Joensuu H, Holli K, Heikkinen M, Suonio E, Aro AR, Hietanen P, et. al. Combination chemotherapy versus single agent therapy as first- and second-line treatment in. Journal of Clinical Oncology 1998; 16(12):3720-30.
25. Nabholtz JM, Senn HJ, Bezwoda WR, Melnychuk D, Deschenes L, Douma J, et. al. Prospective randomized trial of docetaxel versus mitomycin plus vinblastine in patients with. Journal of Clinical Oncology 1999; 17(5):1413-1424.
26. Nielsen D, Dombernowsky P, Skovsgaard T, Jensen J, Andersen E, Engelholm SA, et. al. Epirubicin or epirubicin and vindesine in advanced breast cancer. A phase III study. Annals of Oncology 1990; 1(4):275-80.
27. Nielsen D, Dombernowsky P, Larsen SK, Hansen OP, Skovsgaard T. Epirubicin or epirubicin and cisplatin as first line therapy in advanced breast cancer. A phase III. Cancer Chemotherapy & Pharmacology 2000; 46(6):459-66.
28. Norris B, Pritchard KI, Myles JJ, Bennett K, Marlin S, Skillings J, et. al. Phase III comparative study of vinorelbine combined with doxorubicin versus doxorubicin alone in disseminated metastic/recurrent breast cancer: National cancer institute of Canada Clinical Trials Group Study MA8. Journal of Clinical Oncology 2000; 18:2385-94.
29. O'Shaughnessy JA, Blum J, Moiseyenko V, Jones SE, Miles D, Bell D, et. al. Randomised, open-label, phase II trial of oral capecitabine vs. a reference arm of intravenous CMF (cyclophosphamide, methotrexate and 5-fluorouracil) as first-line therapy for advanced breast cancer. Annals of Oncology 2001; 12:1247-54.
30. O'Shaughnessy J, Miles D, Vukelja S, Moiseyenko V, Ayoub JP, Cervantes G, et. al. Superior survival with capecitabine plus docetaxel combination therapy in anthracycline-pretreated patients with advanced breast cancer: phase III trial results. Journal of Clinical Oncology 2002; 20(12):2812-23.
31. Sjostrom J, Blomqvist C, Mouridsen H, Pluzanska A, Ottosson-Lonn S, Bengtsson NO. Docetaxel compared with sequential methotrexate and 5-fluorouracil in patients with advanced. European Journal of Cancer 1999; 35(8):1194-1201.
32. Sledge GW, Neuberg D, Bernardo P, Ingle J, Martino S, Rowinsky EK, et. al. Phase III trials of Doxorubicin, Paclitaxel, and the Combination of Doxorubicin and Paclitaxel as Front Line Chemotherapy for Metastatic Breast Cancer: An Intergroup Trial (EII93). Journal of Clinical Oncology 2003; 21(4):588-92.
33. Stockler MR, Sourjina T, Harvey V, Francis P, Byrne M, Hazel VG, et. al. A randomized trial of capecitabine given intermittently versus continuously versus classical CMF as first line chemotherapy for women with advanced breast can-cer unsuited to more intensive treatment. Proceedings of the American Society of Clinical Oncolcogy. 2006; Vol. Abstract 6066.
34. Takayama T, Nomura Y. A double-blind randomized comparative study of oral 5-fluorouracil (5-FU), cyclophosphamide. Japanese Journal of Cancer & Chemotherapy 2000; 27(1):73-80.
35. Tashiro H, Nomura Y, Ohsaki A. A double blind comparative study of (FT) and UFT. Japanese Journal of Clinical Oncology 1994; 24(4):212-17.
36. Thomas ES, Gomez HL, Li RK, Chung HC, Fein LE, Chan VF, et. al. Ixabepilone Plus Capecitabine for Metastatic Breast Cancer Progressing After Anthracycline and Taxane Treatment Ixabepilone Plus Capecitabine for Metastatic Breast Cancer Progressing After Anthracycline and Taxane Treatment. Journal of Clinical Oncology 2008; 25(33):5210-17.
37. Venturino A, Comandini D, Simoni C, Merlini L, Naso C, Palumbo R, et. al. Is salvage chemotherapy for metastatic breast cancer always effective and well tolerated? Breast Cancer Research & Treatment 2000; 60(3):195-200.
38. Early Breast Cancer Trialists' Collaborative Group: Systemic treatment of early breast cancer by hormonal, cytotoxic, or immune therapy. Lancet 1992; 339:1-15.
39. Henderson IC. Chemotherapy for metastatic disease. In: Harris J, Hellman S, Henderson IC, eds. Breast Diseases, Second Edition. Philadelphia: J.B. Lippincott Company, 1991, pp. 604–665.
40. Ellis M, Hayes DF, Lippman ME. Treatment of metastatic breast cancer. In: Harris JR, Lippman ME, Morrow M et al., eds. Disease of the Breast, Second Edition. Philadelphia: Lippincott Williams & Wilkins, 2000, pp. 749.
41. Hortobagyi GN. Treatment of breast cancer. N Engl J Med 1998; 339:974–984.
42. Canellos GP, Pocock SJ, Taylor SG. Combination chemotherapy for metastatic breast carcinoma. Prospective comparison of multiple drug therapy with L-phenylalanine mustard. Cancer 1976; 38:1882–1886.
43. Rubens RD, Knight RK, Hayward JL. Chemotherapy of advanced breast cancer: A controlled randomized trial of cyclophosphamide versus a four drug combination. Br J Cancer 1975; 32:730 –736.
44. Carmo-Pereira J, Costa FO, Henriques E. Single drug vs combination cytotoxic chemotherapy in advanced breast cancer: A randomized study. Eur J Cancer 1980; 16:1621–1625.
45. Steiner R, Stewart JF, Cantwell BM. Adriamycin alone or combined with vincristine in the treatment of advanced breast cancer. Eur J Cancer Clin Oncol 1983; 19:1553–1557.
46. Andersson M, Daugaard S, von der Maase H. Doxorubicin versus mitomycin versus doxorubicin plus mitomycin in advanced breast cancer: A randomized study. Cancer Treat Rep 1986; 70:1181–1186.
47. Gundersen S, Kvinnsland S, Klepp O. Weekly Adriamycin versus VAC in advanced breast cancer. A randomized trial. Eur J Cancer Clin Oncol 1986; 22:1431–1434.
48. Ahmann DL, Schaid DJ, Bisel HF. The effect on survival of initial chemotherapy in advanced breast cancer: Polychemotherapy versus single drug. J Clin Oncol 1987; 5:1928 –1932.
49. Vaughn CB, Green SJ, O’Bryan R. VP-16_Adriamycin vs. Adriamycin alone in advanced adenocarcinoma of the breast, phase II, a randomized trial: A Southwest Oncology Group study. Med Pediatr Oncol 1988; 16:312–319.
50. A’Hern RP, Smith IE, Ebbs SR. Chemotherapy and survival in advanced breast cancer: The inclusion of doxorubicin in Cooper type regimens. Br J Cancer 1993; 67:801– 805.
51. Alba E, Martin M, Ramos M. 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. J Clin Oncol 2004; 22:2587–2593.
52. Conte PF, Guarneri V, Bruzzi P. Concomitant versus sequential administration of epirubicin and paclitaxel as first-line therapy in metastatic breast carcinoma: Results for the Gruppo Oncologico Nord Ovest randomized trial. Cancer 2004; 101:704 –712.
53. Koroleva I, Wojtukiewicz M, Za-luski J. Preliminary results of a phase II randomized trial of Taxotere (T) and doxorubicin (A) given in combination or sequentially as first line chemotherapy (CT) for metastatic breast cancer (MBC). Proc Am Soc Clin Oncol 2001; 20:30a.
54. Fountzilas G, Papadimitriou C, Dafni U. Dose-dense sequential chemotherapy with epirubicin and paclitaxel versus the combination, as first line chemotherapy, in ad-vanced breast cancer: A randomized study conducted by the Hel-lenic Cooperative Oncology Group. J Clin Oncol 2001; 19:2232–2239.
55. Cresta S, Grasselli G, Mansutti M. 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. Ann Oncol 2004; 15:433– 439.
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“A META-ANALYSIS STUDY OF POLYCHEMOTHERAPY VERSUS MONOCHEMOTHERAPY IN PATIENTS OF METASTATIC BREAST CANCER”. International Journal of Pharmaceutical Sciences and Drug Research, vol. 8, no. 3, May 2016, pp. 134-43, https://doi.org/10.25004/IJPSDR.2016.080302.
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“A META-ANALYSIS STUDY OF POLYCHEMOTHERAPY VERSUS MONOCHEMOTHERAPY IN PATIENTS OF METASTATIC BREAST CANCER”. International Journal of Pharmaceutical Sciences and Drug Research, vol. 8, no. 3, May 2016, pp. 134-43, https://doi.org/10.25004/IJPSDR.2016.080302.
