The Experts below are selected from a list of 39 Experts worldwide ranked by ideXlab platform

Anne Kiil Berthelsen - One of the best experts on this subject based on the ideXlab platform.

  • A randomized double-blind phase III study of nimorazole as a hypoxic radiosensitizer of primary radiotherapy in supraglottic larynx and Pharynx Carcinoma. Results of the Danish Head and Neck Cancer Study (DAHANCA) Protocol 5-85
    Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology, 1998
    Co-Authors: Jens Overgaard, Birgit Lindelov, Marie Overgaard, Anne Kiil Berthelsen, Hanne Sand Hansen, Lars Bastholt, Lena Specht, Karsten Jorgensen
    Abstract:

    Purpose: A multicenter randomized and balanced double-blind trial with the objective of assessing the efficacy and tolerance of nimorazole given as a hypoxic radiosensitizer in conjunction with primary radiotherapy of invasive Carcinoma of the supraglottic larynx and Pharynx. Patients and treatment: Between January 1986 and September 1990, 422 patients (414 eligible) with Pharynx and supraglottic larynx Carcinoma were double-blind randomized to receive the hypoxic cell radiosensitizer nimorazole, or placebo, in association with conventional primary radiotherapy (62–68 Gy, 2 Gy per fraction, five fractions per week). The median observation time was 112 months. Results: Univariate analysis showed that the outcome (5-year actuarial loco-regional tumor control) was significantly related to T-classification (T1–T2 48% versus T3–T4 36%, P=0.0008), neck-nodes (N− 53% versus N+ 33%), pre-irradiation hemoglobin (Hb) concentration (high 46% versus low 37%, P=0.02) and sex (females 51% versus males 38%, P=0.03). Overall the nimorazole group showed a significantly better loco-regional control rate than the placebo group (49 versus 33%, P=0.002). A similar significant benefit of nimorazole was observed for the end-points of final loco-regional control (including surgical salvage) and cancer-related deaths (52 versus 41%, P=0.002). This trend was also found in the overall survival but to a lesser, non-significant extent (26 versus 16%, 10-year actuarial values, P=0.32). Cox multivariate regression analysis showed the most important prognostic parameters for loco-regional control to be positive neck nodes (relative risk 1.84 (1.38–2.45)), T3–T4 tumor (relative risk 1.65 (1.25–2.17)) and nimorazole (relative risk 0.69 (0.52–0.90)). The same parameters were also significantly related to the probability of dying from cancer. The compliance to radiotherapy was good and 98% of the patients received the planned dose. Late radiation-related morbidity was observed in 10% of the patients, irrespective of nimorazole treatment. Drug-related side-effects were minor and tolerable with transient nausea and vomiting being the most frequent complications. Conclusion: Nimorazole significantly improves the effect of radiotherapeutic management of supraglottic and Pharynx tumors and can be given without major side-effects.

  • nimorazole as a hypoxic radiosensitizer in the treatment of supraglottic larynx and Pharynx Carcinoma first report from the danish head and neck cancer study dahanca protocol 5 85
    Radiotherapy and Oncology, 1991
    Co-Authors: Jens Overgaard, Sand H Hansen, Birgit Lindelov, Marie Overgaard, Karsten Jorgensen, B Rasmusson, Anne Kiil Berthelsen
    Abstract:

    Abstract Between January 1986 and September 1990, 422 patients with Pharynx and supraglottic larynx Carcinoma were randomized to receive the hypoxic cell radiosensitizer nimorazole (NIM) or placebo in association with a course of conventional primary radiotherapy. A preliminary analysis including the first 288 patients showed that the stratification parameters were significant (3-year actuarial local-regional tumor control, p

  • nimorazole as a hypoxic radiosensitizer in the treatment of supraglottic larynx and Pharynx Carcinoma first report from the danish head and neck cancer study dahanca protocol 5 85
    Radiotherapy and Oncology, 1991
    Co-Authors: Jens Overgaard, Sand H Hansen, Birgit Lindelov, Marie Overgaard, Karsten Jorgensen, B Rasmusson, Anne Kiil Berthelsen
    Abstract:

    Between January 1986 and September 1990, 442 patients with Pharynx and supraglottic larynx Carcinoma were randomized to receive the hypoxic cell radiosensitizer nimorazole (NIM) or placebo in association with a course of conventional primary radiotherapy. A preliminary analysis including the first 288 patients showed that the stratification parameters were significant (3-year actuarial local-regional tumor control, p less than 0.05) for sex (females 52% vs males 34%), tumor size (T1-T2 47% vs T3-T4 32%) and pre-irradiation hemoglobin (Hb) concentration (high 41% vs low 34%). Overall, the NIM group showed a significantly better local-regional control rate than the placebo group (46% vs 32%). There was an apparent additive effect of Hb concentration and NIM. Thus, in the male group, placebo patients with low Hb had a 23% control rate compared to 46% in NIM treated patients with Hb above 9 mmol/l (p less than 0.05). The similar effect in females could not be evaluated due to the small number of women with this disease. NIM was well tolerated and drug-related side effects were minor and tolerable, with transient nausea and vomiting as the most frequent complication. A final conclusion of the study must await an evaluation including all patients and a longer observation time.

Jens Overgaard - One of the best experts on this subject based on the ideXlab platform.

  • A randomized double-blind phase III study of nimorazole as a hypoxic radiosensitizer of primary radiotherapy in supraglottic larynx and Pharynx Carcinoma. Results of the Danish Head and Neck Cancer Study (DAHANCA) Protocol 5-85
    Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology, 1998
    Co-Authors: Jens Overgaard, Birgit Lindelov, Marie Overgaard, Anne Kiil Berthelsen, Hanne Sand Hansen, Lars Bastholt, Lena Specht, Karsten Jorgensen
    Abstract:

    Purpose: A multicenter randomized and balanced double-blind trial with the objective of assessing the efficacy and tolerance of nimorazole given as a hypoxic radiosensitizer in conjunction with primary radiotherapy of invasive Carcinoma of the supraglottic larynx and Pharynx. Patients and treatment: Between January 1986 and September 1990, 422 patients (414 eligible) with Pharynx and supraglottic larynx Carcinoma were double-blind randomized to receive the hypoxic cell radiosensitizer nimorazole, or placebo, in association with conventional primary radiotherapy (62–68 Gy, 2 Gy per fraction, five fractions per week). The median observation time was 112 months. Results: Univariate analysis showed that the outcome (5-year actuarial loco-regional tumor control) was significantly related to T-classification (T1–T2 48% versus T3–T4 36%, P=0.0008), neck-nodes (N− 53% versus N+ 33%), pre-irradiation hemoglobin (Hb) concentration (high 46% versus low 37%, P=0.02) and sex (females 51% versus males 38%, P=0.03). Overall the nimorazole group showed a significantly better loco-regional control rate than the placebo group (49 versus 33%, P=0.002). A similar significant benefit of nimorazole was observed for the end-points of final loco-regional control (including surgical salvage) and cancer-related deaths (52 versus 41%, P=0.002). This trend was also found in the overall survival but to a lesser, non-significant extent (26 versus 16%, 10-year actuarial values, P=0.32). Cox multivariate regression analysis showed the most important prognostic parameters for loco-regional control to be positive neck nodes (relative risk 1.84 (1.38–2.45)), T3–T4 tumor (relative risk 1.65 (1.25–2.17)) and nimorazole (relative risk 0.69 (0.52–0.90)). The same parameters were also significantly related to the probability of dying from cancer. The compliance to radiotherapy was good and 98% of the patients received the planned dose. Late radiation-related morbidity was observed in 10% of the patients, irrespective of nimorazole treatment. Drug-related side-effects were minor and tolerable with transient nausea and vomiting being the most frequent complications. Conclusion: Nimorazole significantly improves the effect of radiotherapeutic management of supraglottic and Pharynx tumors and can be given without major side-effects.

  • nimorazole as a hypoxic radiosensitizer in the treatment of supraglottic larynx and Pharynx Carcinoma first report from the danish head and neck cancer study dahanca protocol 5 85
    Radiotherapy and Oncology, 1991
    Co-Authors: Jens Overgaard, Sand H Hansen, Birgit Lindelov, Marie Overgaard, Karsten Jorgensen, B Rasmusson, Anne Kiil Berthelsen
    Abstract:

    Abstract Between January 1986 and September 1990, 422 patients with Pharynx and supraglottic larynx Carcinoma were randomized to receive the hypoxic cell radiosensitizer nimorazole (NIM) or placebo in association with a course of conventional primary radiotherapy. A preliminary analysis including the first 288 patients showed that the stratification parameters were significant (3-year actuarial local-regional tumor control, p

  • nimorazole as a hypoxic radiosensitizer in the treatment of supraglottic larynx and Pharynx Carcinoma first report from the danish head and neck cancer study dahanca protocol 5 85
    Radiotherapy and Oncology, 1991
    Co-Authors: Jens Overgaard, Sand H Hansen, Birgit Lindelov, Marie Overgaard, Karsten Jorgensen, B Rasmusson, Anne Kiil Berthelsen
    Abstract:

    Between January 1986 and September 1990, 442 patients with Pharynx and supraglottic larynx Carcinoma were randomized to receive the hypoxic cell radiosensitizer nimorazole (NIM) or placebo in association with a course of conventional primary radiotherapy. A preliminary analysis including the first 288 patients showed that the stratification parameters were significant (3-year actuarial local-regional tumor control, p less than 0.05) for sex (females 52% vs males 34%), tumor size (T1-T2 47% vs T3-T4 32%) and pre-irradiation hemoglobin (Hb) concentration (high 41% vs low 34%). Overall, the NIM group showed a significantly better local-regional control rate than the placebo group (46% vs 32%). There was an apparent additive effect of Hb concentration and NIM. Thus, in the male group, placebo patients with low Hb had a 23% control rate compared to 46% in NIM treated patients with Hb above 9 mmol/l (p less than 0.05). The similar effect in females could not be evaluated due to the small number of women with this disease. NIM was well tolerated and drug-related side effects were minor and tolerable, with transient nausea and vomiting as the most frequent complication. A final conclusion of the study must await an evaluation including all patients and a longer observation time.

Karsten Jorgensen - One of the best experts on this subject based on the ideXlab platform.

  • A randomized double-blind phase III study of nimorazole as a hypoxic radiosensitizer of primary radiotherapy in supraglottic larynx and Pharynx Carcinoma. Results of the Danish Head and Neck Cancer Study (DAHANCA) Protocol 5-85
    Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology, 1998
    Co-Authors: Jens Overgaard, Birgit Lindelov, Marie Overgaard, Anne Kiil Berthelsen, Hanne Sand Hansen, Lars Bastholt, Lena Specht, Karsten Jorgensen
    Abstract:

    Purpose: A multicenter randomized and balanced double-blind trial with the objective of assessing the efficacy and tolerance of nimorazole given as a hypoxic radiosensitizer in conjunction with primary radiotherapy of invasive Carcinoma of the supraglottic larynx and Pharynx. Patients and treatment: Between January 1986 and September 1990, 422 patients (414 eligible) with Pharynx and supraglottic larynx Carcinoma were double-blind randomized to receive the hypoxic cell radiosensitizer nimorazole, or placebo, in association with conventional primary radiotherapy (62–68 Gy, 2 Gy per fraction, five fractions per week). The median observation time was 112 months. Results: Univariate analysis showed that the outcome (5-year actuarial loco-regional tumor control) was significantly related to T-classification (T1–T2 48% versus T3–T4 36%, P=0.0008), neck-nodes (N− 53% versus N+ 33%), pre-irradiation hemoglobin (Hb) concentration (high 46% versus low 37%, P=0.02) and sex (females 51% versus males 38%, P=0.03). Overall the nimorazole group showed a significantly better loco-regional control rate than the placebo group (49 versus 33%, P=0.002). A similar significant benefit of nimorazole was observed for the end-points of final loco-regional control (including surgical salvage) and cancer-related deaths (52 versus 41%, P=0.002). This trend was also found in the overall survival but to a lesser, non-significant extent (26 versus 16%, 10-year actuarial values, P=0.32). Cox multivariate regression analysis showed the most important prognostic parameters for loco-regional control to be positive neck nodes (relative risk 1.84 (1.38–2.45)), T3–T4 tumor (relative risk 1.65 (1.25–2.17)) and nimorazole (relative risk 0.69 (0.52–0.90)). The same parameters were also significantly related to the probability of dying from cancer. The compliance to radiotherapy was good and 98% of the patients received the planned dose. Late radiation-related morbidity was observed in 10% of the patients, irrespective of nimorazole treatment. Drug-related side-effects were minor and tolerable with transient nausea and vomiting being the most frequent complications. Conclusion: Nimorazole significantly improves the effect of radiotherapeutic management of supraglottic and Pharynx tumors and can be given without major side-effects.

  • nimorazole as a hypoxic radiosensitizer in the treatment of supraglottic larynx and Pharynx Carcinoma first report from the danish head and neck cancer study dahanca protocol 5 85
    Radiotherapy and Oncology, 1991
    Co-Authors: Jens Overgaard, Sand H Hansen, Birgit Lindelov, Marie Overgaard, Karsten Jorgensen, B Rasmusson, Anne Kiil Berthelsen
    Abstract:

    Abstract Between January 1986 and September 1990, 422 patients with Pharynx and supraglottic larynx Carcinoma were randomized to receive the hypoxic cell radiosensitizer nimorazole (NIM) or placebo in association with a course of conventional primary radiotherapy. A preliminary analysis including the first 288 patients showed that the stratification parameters were significant (3-year actuarial local-regional tumor control, p

  • nimorazole as a hypoxic radiosensitizer in the treatment of supraglottic larynx and Pharynx Carcinoma first report from the danish head and neck cancer study dahanca protocol 5 85
    Radiotherapy and Oncology, 1991
    Co-Authors: Jens Overgaard, Sand H Hansen, Birgit Lindelov, Marie Overgaard, Karsten Jorgensen, B Rasmusson, Anne Kiil Berthelsen
    Abstract:

    Between January 1986 and September 1990, 442 patients with Pharynx and supraglottic larynx Carcinoma were randomized to receive the hypoxic cell radiosensitizer nimorazole (NIM) or placebo in association with a course of conventional primary radiotherapy. A preliminary analysis including the first 288 patients showed that the stratification parameters were significant (3-year actuarial local-regional tumor control, p less than 0.05) for sex (females 52% vs males 34%), tumor size (T1-T2 47% vs T3-T4 32%) and pre-irradiation hemoglobin (Hb) concentration (high 41% vs low 34%). Overall, the NIM group showed a significantly better local-regional control rate than the placebo group (46% vs 32%). There was an apparent additive effect of Hb concentration and NIM. Thus, in the male group, placebo patients with low Hb had a 23% control rate compared to 46% in NIM treated patients with Hb above 9 mmol/l (p less than 0.05). The similar effect in females could not be evaluated due to the small number of women with this disease. NIM was well tolerated and drug-related side effects were minor and tolerable, with transient nausea and vomiting as the most frequent complication. A final conclusion of the study must await an evaluation including all patients and a longer observation time.

Birgit Lindelov - One of the best experts on this subject based on the ideXlab platform.

  • A randomized double-blind phase III study of nimorazole as a hypoxic radiosensitizer of primary radiotherapy in supraglottic larynx and Pharynx Carcinoma. Results of the Danish Head and Neck Cancer Study (DAHANCA) Protocol 5-85
    Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology, 1998
    Co-Authors: Jens Overgaard, Birgit Lindelov, Marie Overgaard, Anne Kiil Berthelsen, Hanne Sand Hansen, Lars Bastholt, Lena Specht, Karsten Jorgensen
    Abstract:

    Purpose: A multicenter randomized and balanced double-blind trial with the objective of assessing the efficacy and tolerance of nimorazole given as a hypoxic radiosensitizer in conjunction with primary radiotherapy of invasive Carcinoma of the supraglottic larynx and Pharynx. Patients and treatment: Between January 1986 and September 1990, 422 patients (414 eligible) with Pharynx and supraglottic larynx Carcinoma were double-blind randomized to receive the hypoxic cell radiosensitizer nimorazole, or placebo, in association with conventional primary radiotherapy (62–68 Gy, 2 Gy per fraction, five fractions per week). The median observation time was 112 months. Results: Univariate analysis showed that the outcome (5-year actuarial loco-regional tumor control) was significantly related to T-classification (T1–T2 48% versus T3–T4 36%, P=0.0008), neck-nodes (N− 53% versus N+ 33%), pre-irradiation hemoglobin (Hb) concentration (high 46% versus low 37%, P=0.02) and sex (females 51% versus males 38%, P=0.03). Overall the nimorazole group showed a significantly better loco-regional control rate than the placebo group (49 versus 33%, P=0.002). A similar significant benefit of nimorazole was observed for the end-points of final loco-regional control (including surgical salvage) and cancer-related deaths (52 versus 41%, P=0.002). This trend was also found in the overall survival but to a lesser, non-significant extent (26 versus 16%, 10-year actuarial values, P=0.32). Cox multivariate regression analysis showed the most important prognostic parameters for loco-regional control to be positive neck nodes (relative risk 1.84 (1.38–2.45)), T3–T4 tumor (relative risk 1.65 (1.25–2.17)) and nimorazole (relative risk 0.69 (0.52–0.90)). The same parameters were also significantly related to the probability of dying from cancer. The compliance to radiotherapy was good and 98% of the patients received the planned dose. Late radiation-related morbidity was observed in 10% of the patients, irrespective of nimorazole treatment. Drug-related side-effects were minor and tolerable with transient nausea and vomiting being the most frequent complications. Conclusion: Nimorazole significantly improves the effect of radiotherapeutic management of supraglottic and Pharynx tumors and can be given without major side-effects.

  • nimorazole as a hypoxic radiosensitizer in the treatment of supraglottic larynx and Pharynx Carcinoma first report from the danish head and neck cancer study dahanca protocol 5 85
    Radiotherapy and Oncology, 1991
    Co-Authors: Jens Overgaard, Sand H Hansen, Birgit Lindelov, Marie Overgaard, Karsten Jorgensen, B Rasmusson, Anne Kiil Berthelsen
    Abstract:

    Abstract Between January 1986 and September 1990, 422 patients with Pharynx and supraglottic larynx Carcinoma were randomized to receive the hypoxic cell radiosensitizer nimorazole (NIM) or placebo in association with a course of conventional primary radiotherapy. A preliminary analysis including the first 288 patients showed that the stratification parameters were significant (3-year actuarial local-regional tumor control, p

  • nimorazole as a hypoxic radiosensitizer in the treatment of supraglottic larynx and Pharynx Carcinoma first report from the danish head and neck cancer study dahanca protocol 5 85
    Radiotherapy and Oncology, 1991
    Co-Authors: Jens Overgaard, Sand H Hansen, Birgit Lindelov, Marie Overgaard, Karsten Jorgensen, B Rasmusson, Anne Kiil Berthelsen
    Abstract:

    Between January 1986 and September 1990, 442 patients with Pharynx and supraglottic larynx Carcinoma were randomized to receive the hypoxic cell radiosensitizer nimorazole (NIM) or placebo in association with a course of conventional primary radiotherapy. A preliminary analysis including the first 288 patients showed that the stratification parameters were significant (3-year actuarial local-regional tumor control, p less than 0.05) for sex (females 52% vs males 34%), tumor size (T1-T2 47% vs T3-T4 32%) and pre-irradiation hemoglobin (Hb) concentration (high 41% vs low 34%). Overall, the NIM group showed a significantly better local-regional control rate than the placebo group (46% vs 32%). There was an apparent additive effect of Hb concentration and NIM. Thus, in the male group, placebo patients with low Hb had a 23% control rate compared to 46% in NIM treated patients with Hb above 9 mmol/l (p less than 0.05). The similar effect in females could not be evaluated due to the small number of women with this disease. NIM was well tolerated and drug-related side effects were minor and tolerable, with transient nausea and vomiting as the most frequent complication. A final conclusion of the study must await an evaluation including all patients and a longer observation time.

Marie Overgaard - One of the best experts on this subject based on the ideXlab platform.

  • A randomized double-blind phase III study of nimorazole as a hypoxic radiosensitizer of primary radiotherapy in supraglottic larynx and Pharynx Carcinoma. Results of the Danish Head and Neck Cancer Study (DAHANCA) Protocol 5-85
    Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology, 1998
    Co-Authors: Jens Overgaard, Birgit Lindelov, Marie Overgaard, Anne Kiil Berthelsen, Hanne Sand Hansen, Lars Bastholt, Lena Specht, Karsten Jorgensen
    Abstract:

    Purpose: A multicenter randomized and balanced double-blind trial with the objective of assessing the efficacy and tolerance of nimorazole given as a hypoxic radiosensitizer in conjunction with primary radiotherapy of invasive Carcinoma of the supraglottic larynx and Pharynx. Patients and treatment: Between January 1986 and September 1990, 422 patients (414 eligible) with Pharynx and supraglottic larynx Carcinoma were double-blind randomized to receive the hypoxic cell radiosensitizer nimorazole, or placebo, in association with conventional primary radiotherapy (62–68 Gy, 2 Gy per fraction, five fractions per week). The median observation time was 112 months. Results: Univariate analysis showed that the outcome (5-year actuarial loco-regional tumor control) was significantly related to T-classification (T1–T2 48% versus T3–T4 36%, P=0.0008), neck-nodes (N− 53% versus N+ 33%), pre-irradiation hemoglobin (Hb) concentration (high 46% versus low 37%, P=0.02) and sex (females 51% versus males 38%, P=0.03). Overall the nimorazole group showed a significantly better loco-regional control rate than the placebo group (49 versus 33%, P=0.002). A similar significant benefit of nimorazole was observed for the end-points of final loco-regional control (including surgical salvage) and cancer-related deaths (52 versus 41%, P=0.002). This trend was also found in the overall survival but to a lesser, non-significant extent (26 versus 16%, 10-year actuarial values, P=0.32). Cox multivariate regression analysis showed the most important prognostic parameters for loco-regional control to be positive neck nodes (relative risk 1.84 (1.38–2.45)), T3–T4 tumor (relative risk 1.65 (1.25–2.17)) and nimorazole (relative risk 0.69 (0.52–0.90)). The same parameters were also significantly related to the probability of dying from cancer. The compliance to radiotherapy was good and 98% of the patients received the planned dose. Late radiation-related morbidity was observed in 10% of the patients, irrespective of nimorazole treatment. Drug-related side-effects were minor and tolerable with transient nausea and vomiting being the most frequent complications. Conclusion: Nimorazole significantly improves the effect of radiotherapeutic management of supraglottic and Pharynx tumors and can be given without major side-effects.

  • nimorazole as a hypoxic radiosensitizer in the treatment of supraglottic larynx and Pharynx Carcinoma first report from the danish head and neck cancer study dahanca protocol 5 85
    Radiotherapy and Oncology, 1991
    Co-Authors: Jens Overgaard, Sand H Hansen, Birgit Lindelov, Marie Overgaard, Karsten Jorgensen, B Rasmusson, Anne Kiil Berthelsen
    Abstract:

    Abstract Between January 1986 and September 1990, 422 patients with Pharynx and supraglottic larynx Carcinoma were randomized to receive the hypoxic cell radiosensitizer nimorazole (NIM) or placebo in association with a course of conventional primary radiotherapy. A preliminary analysis including the first 288 patients showed that the stratification parameters were significant (3-year actuarial local-regional tumor control, p

  • nimorazole as a hypoxic radiosensitizer in the treatment of supraglottic larynx and Pharynx Carcinoma first report from the danish head and neck cancer study dahanca protocol 5 85
    Radiotherapy and Oncology, 1991
    Co-Authors: Jens Overgaard, Sand H Hansen, Birgit Lindelov, Marie Overgaard, Karsten Jorgensen, B Rasmusson, Anne Kiil Berthelsen
    Abstract:

    Between January 1986 and September 1990, 442 patients with Pharynx and supraglottic larynx Carcinoma were randomized to receive the hypoxic cell radiosensitizer nimorazole (NIM) or placebo in association with a course of conventional primary radiotherapy. A preliminary analysis including the first 288 patients showed that the stratification parameters were significant (3-year actuarial local-regional tumor control, p less than 0.05) for sex (females 52% vs males 34%), tumor size (T1-T2 47% vs T3-T4 32%) and pre-irradiation hemoglobin (Hb) concentration (high 41% vs low 34%). Overall, the NIM group showed a significantly better local-regional control rate than the placebo group (46% vs 32%). There was an apparent additive effect of Hb concentration and NIM. Thus, in the male group, placebo patients with low Hb had a 23% control rate compared to 46% in NIM treated patients with Hb above 9 mmol/l (p less than 0.05). The similar effect in females could not be evaluated due to the small number of women with this disease. NIM was well tolerated and drug-related side effects were minor and tolerable, with transient nausea and vomiting as the most frequent complication. A final conclusion of the study must await an evaluation including all patients and a longer observation time.