13-cis-retinoic acid or All-trans-retinoic acid plus interferon-α in recurrent cervical cancer: A Southwest Oncology Group phase II randomized trial

Gynecologic Oncology

Volumn 71, Issue 3, 1998, Pages 386-390

  Weiss, Geoffrey R ^a   Liu, P Y ^b   Alberts, David S ^c   Peng, Yei Mei ^c   Fisher, Emily ^b   Xu, Min Jian ^c   Scudder, Sidney A ^d   Baker, Laurence H ^e   Moore Jr , Dennis F ^f   Lippman, Scott M ^g  

^a UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO   (United States)

^b SW Oncol Group Statistical Center   (United States)

^c UNIVERSITY OF ARIZONA   (United States)

^d UNIVERSITY OF CALIFORNIA   (United States)

^e UNIVERSITY OF MICHIGAN HEALTH SYSTEM   (United States)

^f WICHITA COMMUNITY CLINICAL ONCOLOGY PROGRAM   (United States)

^g UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALPHA INTERFERON; ALPHA2A INTERFERON; ISOTRETINOIN; RETINOIC ACID;

ADULT; AGED; ANEMIA; ARTHRALGIA; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER IMMUNOTHERAPY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFICACY; DRUG SAFETY; FATIGUE; FEMALE; GRANULOCYTOPENIA; HUMAN; MAJOR CLINICAL STUDY; MALAISE; MYALGIA; ORAL DRUG ADMINISTRATION; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RECURRENT CANCER; SUBCUTANEOUS DRUG ADMINISTRATION; UTERINE CERVIX CARCINOMA; VOMITING;

EID: 0032408337     PISSN: 00908258     EISSN: None     Source Type: Journal    
DOI: 10.1006/gyno.1998.5204     Document Type: Article

References (60)

1. 1. Schottenfeld H, Fraumeni JF, Jr., eds: Cancer Epidemiology and Prevention. 2nd ed. New York, Oxford Press, 1996
2. 2. Parker SL, Tong T, Bolden S, et al.: Cancer statistics, 1997. Ca Cancer J Clin 47:5-27, 1997
3. 3. Eifel PJ, Berek JS, Thigpen JT: Cancer of the Cervix, Vagina, and Vulva. in DeVita VT, Hellman S, Rosenberg SA (eds), Cancer: Principles and Practice of Oncology, 5th ed, Philadelphia, PA, Lippincott-Raven, 1997, pp 1433-1478
4. 4. Davies P, Lippman SM: Biologic basis of retinoid pharmacology: implications for cancer prevention and therapy. Adv Oncol 12:2-10, 1996
5. 5. Kalvakolanu DV, Borden EC: An overview of the interferon system: signal transduction and mechanisms of action. Cancer Inv 14:25-53, 1996
6. 6. Chambon P: A decade of molecular biology of retinoic acid receptors. FASEB J 10:940-954, 1996
7. 7. Lotan R: Retinoids and apoptosis: implication for cancer chemoprevention and therapy. JNCI 87:1655-1657, 1995 (editorial)
8. 8. Lippman SM, Benner SE, Hong WK, et al.: Cancer chemoprevention. J Clin Oncol 12:851-873, 1994
9. 9. Lippman SM, Batsakis JG, Toth BB, et al.: Comparison of low-dose isotretinoin with beta-carotene to prevent oral carcinogenesis. N Engl J Med 328:15-20, 1993
10. 10. Hong WK, Lippman SM, Itri LM, et al.: Prevention of second primary tumor with isotretinoin in squamous cell carcinoma of the head and neck. N Engl J Med 323:795-801, 1990
11. 11. Kraemer KH, DiGiovanni JJ, Moshell AN, et al.: Prevention of skin cancer in xeroderma pigmentosum with the use of oral isotretinoin. N Engl J Med 318:1633-1637, 1988
12. 12. Lotan R, Xu C, Lippman SM, et al.: Suppression of retinoic acid receptor β in oral premalignant lesions and its upregulation by isotretinoin. N Engl J Med 332:1405-1410, 1995
13. 13. Mayne ST, Lippman SM: Retinoids and Carotenoids. in DeVita VT, Hellman S, Rosenberg SA (eds), Cancer: Principles and Practice of Oncology, 5th ed, Philadelphia, PA, Lippincott-Raven, 1997, pp 585-599
14. 14. Bavinck JN, Tieben LM, van der Woude FJ, et al.: Prevention of skin cancer and reduction of keratotic skin lesions during acitretin therapy in renal transplant patients: a double-bind, placebo-controlled study. J Clin Oncol 13:1933-1938, 1995
15. 15. Muto Y, Moriwaki H, Ninomiya M, et al.: Prevention of second primary tumors by an acyclic retinoid, polyprenoic acid, in patients with hepato-cellular carcinoma. N Engl J Med 334:1561-1567, 1996
16. 16. Meyskens FL Jr, Surwit E, Moon TE, et al.: Enhancement of regression of cervical intraepithelial neoplasia II (moderate dysplasia) with topically applied all-trans-retinoic acid: a randomized trial. J Natl Cancer Inst 86:539-543, 1994
17. 17. Warrell RP Jr, Frankel SR, Miller WH Jr, et al.: Differentiation therapy of acute promyelocytic leukemia with tretinoin (all-trans-retinoic acid). N Engl J Med 324:1385-1393, 1991
18. 18. Warrell RP, de The H, Wang ZY, et al.: Acute promyelocytic leukemia. N Engl J Med 329:177-189, 1993
19. 19. Tallman MS, Anderson JW, Schiffer CA, et al.: All-trans-retinoic acid in acute promyelocytic leukemia. N Engl J Med 337:1021-1028, 1997
20. 20. Smith MA, Parkinson DR, Cheson BD, et al.: Retinoids in cancer therapy. J Clin Oncol 10:839-864, 1992
21. 21. Castleberry RP, Emanuel PD, Zuckerman KS, et al.: A pilot study of isotretinoin in the treatment of juvenile chronic myelogenous leukemia. N Engl J Med 331:1680-1684, 1994
22. 22. Cheng A, Su I, Chen C, et al.: Use of retinoic acids in the treatment of peripheral T-cell lymphoma: a pilot study. J Clin Oncol 12:1185-1192, 1994
23. 23. Shalinksy DR, Bischoff ED, Gregory ML, et al.: Enhanced antitumor efficacy of cisplatin in combination with ALRT 1057 (9-cis retinoic acid) in human oral squamous carcinoma xenografts in nude mice. Clin Cancer Res 2:511-520, 1996
24. 24. Aebi S, Kröning R, Cenni B, et al.: All-trans retinoic acid enhances cisplatin-induced apoptosis in human ovarian adenocarcinoma and in squamous head and neck cancer cells. Clin Cancer Res 3:2033-2038, 1997
25. 25. Rutz HP, Little JB: Modification of radiosensitivity and recovery from x-ray damage in vitro by retinoic acid. J Radiat Oncol Biol Phys 16:1285-1288, 1989
26. 26. Schiller U, Hoffmann W, Mayer C, et al.: All-trans-retinoic acid modulates the radiosensitivity and differentiation of normal and tumour cells in vitro. Ann Oncol 5:1-3, 1994
27. 27. Angioli R, Sevin B, Perras JP, et al.: In vitro potentiation of radiation cytotoxicity by recombinant interferons in cervical cancer cell lines. Cancer 71:3717-3725, 1993
28. 28. Benbrook DM, Shen-Gunther J, Nuñez ER, et al.: Differential retinoic acid radiosensitization of cervical carcinoma cell lines. Clin Cancer Res 3:939-945, 1997
29. 29. Hoffmann W, Bamberg M, Rodemann HP: Antiproliferative effects of ionizing radiation, all-trans-retinoic acid and interferon-α on cultured human squamous cell carcinomas. Radiat Oncol Invest 2:12-19, 1994
30. 30. Hoffmann W, Schiebe M, Hirnle P, et al.: 13-cis retinoic acid and interferon-α ± irradiation in the treatment of squamous-cell carcinomas. Int J Cancer 70:475-477, 1997
31. 31. Hänsgen G, Hänsgen K, Dunst J: Oxygen status of cervical cancers prior and during definitive radiotherapy: possible impact of pretreatment with IFN-α-2a/retinoic acid on oxygenation. Int J Radiat Oncol Biol Phys 36:324, 1996 (abstract 2095)
32. 32. DeLaney TF, Afridi N, Taghian AG, et al.: 13-cis-retinoic acid with alpha-2a-interferon enhances radiation cytotoxicity in head and neck squamous cell carcinoma in vitro. Cancer Res 56:2277-2280, 1996
33. 33. Widschwendter M, Daxenbichler G, Dapunt O, et al.: Effects of retinoic acid and gamma-interferon on expression of retinoic acid receptor and cellular retinoic acid-binding protein in breast cancer cells. Cancer Res 55:2135-2139, 1995
34. 34. Widschwendter M, Daxenbichler G, Bachmair F, et al.: Interaction of retinoic acid and interferon-alpha in breast cancer cell lines. Anticancer Res 16:369-374, 1996
35. 35. Fanjul AN, Bouterfa H, Dawson M, et al.: Potential role for retinoic acid receptor gamma in the inhibition of breast cancer cells by selective retinoids and interferons. Cancer Res 56:1571-1577, 1996
36. 36. Gianni M, Zanotta S, Terao M, et al.: Interferons induce the expression of retinoic acid receptors and potentiate the cyto-differentiating activity of retinoids in APL cells. Int J Cancer 68:75, 1996
37. 37. Agarwal C, Hembree JR, Rorke PA, et al.: Interferon and retinoic acid suppress the growth of human papillomavirus type-16 immortalized cervical epithelial cells, but only interferon suppresses the level of the human papillomavirus transforming oncogenes. Cancer Res 54:2108-2112, 1994
38. 38. Lancillotti F, Giandomenico V, Affabris E, et al.: Interferon alpha-2b and retinoic acid combined treatment affects proliferation and gene expression of human cervical carcinoma cells. Cancer Res 55:3158-3164, 1995
39. 39. Lotan R, Dawson MI, Zou C-C, et al.: Enhanced efficacy of combinations of retinoic acid- and retinoid X receptor-selective retinoids and α-interferon in inhibition of cervical carcinoma cell proliferation. Cancer Res 55:232-236, 1995
40. 40. Massad LS, Turyk ME, Bitterman P, Wilbanks GD: Interferon-α and all-trans-retinoic acid reversibly inhibit the in vitro proliferation of cell lines derived from cervical cancers. Gynecol Oncol 60:428-434, 1996
41. 41. Cippitelli M, Ye J, Viggiano V, et al.: Retinoic acid-induced transcriptional modulation of the human interferon-γ promoter. J Biol Chem 271:26783-26793, 1996
42. 42. Kolla V, Lindner DJ, Weihua X, et al.: Modulation of interferon-inducible gene expression by retinoic acid: upregulation of stat 1 protein in IFN-unresponsive cells. J Biol Chem 271:10508-10514, 1996
43. 43. Gianni M, Terao M, Fortino I, et al.: Stat1 is induced and activated by all-trans retinoic acid in acute promyelocytic leukemia cells. Blood 89: 1001-1012, 1997
44. 44. Weihua X, Kolla V, Kalvakolanu DV: Modulation of interferon action by retinoids. J Biol Chem 272:9742-9748, 1997
45. WAF1/CIP1 gene by retinoic acid receptor. J Biol Chem 271: 31723-31728, 1996
46. WAF1/CIP1 mediated by STAT1. Science 272:719-722, 1996
47. 47. Lindner DJ, Borden EC, Kalvakolanu DV: Synergistic antitumor effects of a combination of interferons and retinoic acid on human tumor cells in vitro and in vivo. Clin Cancer Res 3:931-937, 1997
48. 48. Majewski S, Szmurlo A, Marczak M, et al.: Synergistic effect of retinoids and interferon alpha on tumor-induced angiogenesis: anti-angiogenic effect on HPV-harboring tumor-cell lines. Int J Cancer 57:81-85, 1994
49. 49. Lippman SM, Parkinson DR, Itri LM, et al.: 13-cis-retinoic acid and interferon-2a. Effective combination therapy for advanced squamous cell carcinoma of the skin. J Natl Cancer Inst 84:235-240, 1992
50. 50. Toma S, Palumbo R, Vincenti M: Efficacy of recombinant interferon-alpha and 13-cis-retinoic acid in the treatment of squamous cell carcinomas. Ann Oncol 5:463-465, 1994
51. 51. Lippman SM, Kavanagh JJ, Paredes-Espinoza MM, et al.: 13-cis retinoic acid plus interferon alpha 2a: in locally advanced squamous cell carcinoma of the cervix. J Natl Cancer Inst 85:499-500, 1993
52. 52. Lippman SM, Kavanagh JJ, Paredez-Espinoza M, et al.: 13-cis retinoic acid plus interferon-alpha2a: highly active systemic therapy for squamous cell carcinoma of the cervix. J Natl Cancer Inst 84:214-245, 1992
53. 53. Kavanagh JJ, Lippman SM, Paredes-Espinoza M: The combination of 13-cis-retinoic acid and interferon α2a with radiation therapy in squamous cell carcinoma of the cervix. Int J Gynecol Cancer 6:439-444, 1996
54. 54. Motzer RJ, Schwartz L, Law TM, et al.: Interferon alfa-2a and 13-cis retinoic acid in renal cell carcinoma: antitumor activity in a phase II trial and interactions in vitro. J Clin Oncol 13:1950-1957, 1995
55. 55. Green S, Weiss GR: Southwest Oncology Group standard response criteria, endpoint definitions and toxicity criteria. Inv New Drugs 10:239-253, 1992
56. 56. Bugge CJL, Rodriguez LC, Vane FM: Determination of isotretinoin or etretinate and their major metabolites in human blood by reversed-phase high-performance liquid chromatography. J Pharm Biomed Anal 3:269-277, 1985
57. 57. Green SJ, Dahlberg S. Planned versus attained design in phase II clinical trials. Stat Med 11:853-862, 1992
58. 58. Antonadou D, Cardamakis E, Iliopoulos P, et al.: Comparative study between exclusive irradiation or combined with IFN-α-2a and isotretinoin in stage IIb and III cervical carcinoma. ASTRO 36:121, 1996 (abstract 122)
59. 2a in heavily pretreated squamous carcinoma of the cervix. Gynecol Oncol 56:382-386, 1995
60. 60. Wadler S, Schwartz EL, Haynes H, et al.: All-trans retinoic acid and interferon-α-2a in patients with metastatic or recurrent carcinoma of the uterine cervix. Cancer 79:1574-1580, 1997